2013 年 11 月のメッドテック リコール

December 4, 2013 By Arezu Sarvestani

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Baylis Medical Corp * Nov-01-2013 TorFlex – Baylis Medical TorFlex Transseptal Guiding Sheath; Rx Only; non-pyrogenic; sterile.Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath; a dilator; and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream.

Medtronic Vascular Nov-15-2013 Zinger¿ Stainless Steel Workhorse Guidewire – Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ; ZNGRLS180HS; ZNGRMS180HJ; ZNGRMS180HS; ZNGRMS180S; ZNGRS180HJ; ZNGRS180HS; ZNGRS180SMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Medtronic Vascular Nov-15-2013 Cougar¿ Nitinol Workhorse Guidewire – Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ; CGRLS190HS; CGRLS190S; CGRLS300HS; CGRLS300S. CGRXT190HJ; CGRXT190HS; CGRXT190J; CGRXT190S; CGRXT300HJ; CGRXT300HS; CGRXT300J; CGRXT300SMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Medtronic Vascular Nov-15-2013 THUNDER¿ Steerable Guidewire – THUNDER¿ Extra Support Guidewire; Models: THNDR190J; THNDR190S; THNDR300J; THNDR300SMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Medtronic Vascular Nov-15-2013 ProVia¿ CROSSING GUIDEWIRE – ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS; 3PROV180HS; 3PROV180SS; 3PROV300HS; 3PROV300SSMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices inthe coronary and peripheral vasculature; and may be used to reach and cross atarget lesion. Medtronic guide wires are not intended for cerebral vasculature.Medt

Medtronic Vascular Nov-15-2013 ATTAIN HYBRID¿ Guide Wire – ATTAIN HYBRID¿ Guide Wire; Models: GWR419478; GWR419488; GWR419688The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Medtronic Vascular Nov-15-2013 COUGAR¿ Steerable Guidewire – COUGAR¿ Steerable Guidewire; Models: LVCLS190J; LVCLS190S; LVCXT190J; LVCXT190SMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Medtronic Vascular Nov-15-2013 THUNDER¿ Steerable Guidewire – THUNDER¿ Steerable Guidewire; Model: LVTNDR190SMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Medtronic Vascular Nov-15-2013 ZINGER¿ Steerable Guidewire – ZINGER¿ Steerable Guidewire; Models: LVZRLS180J; LVZRLS180S; LVZRMS180J; LVZRMS180S; LVZRXT180J; LVZRXT180SMedtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature; and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Del Mar Reynolds Medical; Ltd. Nov-20-2013 BleaseSirius Anesthesia Workstation; BleaseFocus Anesthesia Workstation – CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation; the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100; and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range; Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen; air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator; and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen; air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator; and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. Spacelabs Healthcare Ltd. of United Kingdom recalls ; and Service Kits; Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.

Hospira Inc. Nov-21-2013 Gemstar Infusion System – The GemStar Pump is a small and lightweight; single channel infusion device designed for use in the home; in the hospital; or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor; rechargeable battery pack; docking station; or two disposable AA alkaline batteries. When powered by batteries; The GemStar Pump is ideal for ambulatory patients. The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test; as described in the GemStar Technical Service Manual; or reporting one of the following errors during device setup or infusion: 1) Cassette Check – D; 2) Cassette Check – P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Err

Hospira Inc. Nov-21-2013 Gemstar Infusion System – The GemStar Pump is a small and lightweight; single channel infusion device designed for use in the home; in the hospital; or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor; rechargeable battery pack; docking station; or two disposable AA alkaline batteries. When powered by batteries; The GemStar Pump is ideal for ambulatory patients. The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test; as described in the GemStar Technical Service Manual; or reporting one of the following errors during device setup or infusion: 1) Cassette Check – D; 2) Cassette Check – P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Err

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Siemens Medical Solutions USA; Inc Nov-01-2013 Siemens RAD Fluoro Uro Systems – Siemens RAD Fluoro Uro Systems – Luminos dRF; Ysio and Uroskop Omnia with software versions VB10D; VB10F; VB10C and VB10E. Fluroscopic X-Ray Systems Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D; VB10F; VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally; it is not possible for the user to stop the radiation manually; ho

Smith & Nephew Inc Nov-01-2013 GENESIS(R) II; NON-POROUS TIBIAL BASE; SIZE 6; RIGHT – GENESIS(R) II; NON-POROUS TIBIAL BASE; SIZE 6; RIGHT; QTY: (1); REF 71420188.Product Usage: orthopaedic Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Smith & Nephew Inc Nov-01-2013 GENESIS(R) II; NON-POROUS TIBIAL BASE; SIZE 5; LEFT – GENESIS(R) II; NON-POROUS TIBIAL BASE; SIZE 5; LEFT; QTY: (1); REF 71420168.Product Usage: orthopaedic Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Edwards Lifesciences; LLC Nov-01-2013 Edwards Duraflo coated Dispersion Tip Arterial Cannulae – Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating; Sterile; RX only For Single Use Only; Product Usage:Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

Edwards Lifesciences; LLC Nov-01-2013 Duraflo coated Fem-Flex Arterial Cannula – Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating; DIITFA02225; Sterile; RX only For Single Use Only; Product Usage:Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

EKOS Corporation Nov-01-2013 EKOS EkoSonic Control Unit – The EkoSonic Endovascular System employs high frequency (2-2.5 MHz); low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries.The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids; including thrombolytics; into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable; non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.

Stryker Instruments Div. of Stryker Corporation Nov-01-2013 Dekompressor Percutaneous Discectomy Probe – Dekompressor Percutaneous Discectomy Probe.The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material. Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically; manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece; pain or loss of m

Beckman Coulter Inc. Nov-01-2013 Coulter LH 750 Hematology Analyzer Coulter LH 780 Hematology Analyzer – COULTER¿ LH 750and LH 780 Analyzers.The COULTER LH 750 Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Beckman Coulter is initiating a recall for the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728)

Carestream Health Inc. Nov-01-2013 DRX Revolution Mobile X-ray System – DRX Revolution; Catalog #'s 1)1019397; 2) 1023415 (w/ installation warranty; US-only) and 3) 1023423 (w/ parts warranty; US-only).The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients; in all patient treatment areas Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.

Zimmer; Inc. Nov-01-2013 Ti-Magna Fx Washer-Ti-Versa-FX¿II Femoral Fixation System S/C Plates – Ti-Magna Fx WasherTi-Versa-FX¿II Femoral Fixation System S/C PlatesThe compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck; condyle; or tibia; etc. The washer prevents the screw head from being buried in the bone. Zimmer recently conducted a review of historic packaging validations completed. Based on this review; it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing; to provide statisti

Bayer Healthcare Llc Nov-02-2013 Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS – Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC; Sunnyvale; CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes. Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.

Elekta; Inc. Nov-04-2013 Stereotactic Circular Collimator – 3D Line stereotatic Hardware Accessories – Stereotactic Circular Collimator – 3D Line stereotatic Hardware AccessoriesThe device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. Potential for clinical errors.

Intuitive Surgical; Inc. Nov-04-2013 Patient Cart used in conjunction with the da Vinci S surgical and SI System – Patient Cart used in conjunction with the da Vinci S surgical and SI System.Intuitive Surgical1266 Kifer RoadSunnyvale; CA 94086The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field; assisting the Surgeon Console operator by exchanging instruments and endoscopes; and by performing other patient-side activities. To help ensure patient safety; the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator. Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.

Beckman Coulter Inc. Nov-04-2013 UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems – UniCel DxH 800 and DxH 600 Coulter Cellular Analysis SystemsThe UniCel DxH 800/DxH 600 analyzers are quantitative; multiparameter; automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only. Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb

Richard Wolf Medical Instruments Corp. Nov-04-2013 Bi-Polar Vaporization Electrodes – Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode; sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24;5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode; sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24;5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLFS(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary. Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

Sorin Group Deutschland GmbH Nov-04-2013 Sorin S5 Perfusionn System – S5 Heart-lung machine; Stockert S5 System. Catalogue No: 48-30/40/50-00.The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control.

Insight Instruments; Inc. Nov-04-2013 MLS Torpedo Mini-Light Ophthalmic single-port illumination – MLS Torpedo Mini-Light Ophthalmic single-port illumination.Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired. The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

Medtronic Vascular; Inc. Nov-05-2013 Resolute Integrity Zotarolimus-eluting Coronary Stent – Resolute Integrity Zotarolimus-eluting Coronary Stent:Stent ID 3.0 mm; Stent length 34 mm; Rx; Sterile.Mfg in Medtronic Ireland; Galaway; Ireland. Distributed by: Medtronic Inc.Minneapolis; MN.Indicated for improving coronary luminal diameters in patients. A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.

Insulet Corporation Nov-05-2013 OmniPod Insulin Management System Starter Kit – OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries; a USB cable; a Users Guide; a Soft Carrying Case; a Troubleshooting guide; a Warranty Registration Card; and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger; upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly. Alcohol Prep Pads contained within the kit are not properly labeled.

Insulet Corporation Nov-05-2013 OmniPod Insulin Management Product Demonstration Kit – OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490)Product Usage:The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure; one Alcohol Pad; and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger; upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly. Alcohol Prep Pads contained within the kit are not properly labeled.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Regional Anesthesia Tray with Drugs; 15548-20The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Saddleblock Tray with Drugs 26g Quincke; 4745-20The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Smiths Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Trays – Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope); single-use devices designed to perform epidural; spinal; combined epidural/spinal; nerve block; lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles; introducer needles and accessories required to perform a spinal procedure. Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection; USP; 2 mL Ampoule; NDC # 0409-4712-01; Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Beckman Coulter Inc. Nov-05-2013 Beckman Coulter AU480; AU680; AU5800; and AU5400 Clinical Analyzers – ISE REF Valve; Part No. MU7638 for the AU480; AU680; and AU5800 Chemistry Analyzer.Automated chemistry analyzers that measures analytes in samples. The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present; accuracy of the ISE test results may be affected.

Beckman Coulter Inc. Nov-05-2013 Beckman Coulter AU400; AU640; AU2700; and AU5400 Clinical Analyzers – ISE REF Valve; Part No. MU3226 for the AU400; AU640; AU2700; and AU5400 Chemistry Analyzer.Automated chemistry analyzers that measures analytes in samples. The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present; accuracy of the ISE test results may be affected.

Ethicon Endo-Surgery Inc Nov-05-2013 SAGB QuickClose Swedish Adjustable Gastric Band including Velocity Injection Port and Applier – Adjustable Gastric Band; packaged alone in transparent PETG inner and outer blisters with Tyvek lids.Product Usage:Intended for use in surgical treatment of morbid obesity During aging studies; the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Ethicon Endo-Surgery Inc Nov-05-2013 SAGB QuickClose Swedish Adjustable Gastric Band (with Titanium Port) – Adjustable Gastric Band; packaged alone in transparent PETG inner and outer blisters with Tyvek lids.Product Usage:Intended for use in surgical treatment of morbid obesity During aging studies; the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Ethicon Endo-Surgery Inc Nov-05-2013 REALIZE – Adjustable Gastric Band; packaged alone in transparent PETG inner and outer blisters with Tyvek lids; or in various kit configurations with one band per kit.Product Usage:Intended for use in surgical treatment of morbid obesity During aging studies; the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Roche Diagnostics Operations; Inc. Nov-05-2013 COBAS INTEGRA 800 Analyzer – COBAS INTEGRA 800 Analyzer with software 9864.C2Cobas. COBAS Part Numbers 28122474001; 28122474692; 04559126001; 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. Roche COBAS INTEGRA 800 system; Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed; the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally; certain maintenance activities that have to be performed manually by the operator are not requested on the sof

Fresenius Medical Care Holdings; Inc. Nov-05-2013 Fresenius – Fresenius Liberty¿ CyclerPart Number: RTLR180111Product Usage:The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated; potentially causing peritonitis

Invacare Corporation Nov-05-2013 Aquatec Ocean VIP – Aquatec Ocean VIP; Aquatec Ocean Dual-VIP; Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N; when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched.

Handicare Accessibility Nov-06-2013 Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss); handset – Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss); Part Number BP300-100/BP300-400RSUS (handset) – Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver)Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift; a non-AC-powered patient lift consisting of a motorized actuator; powered mechanical seating device; temporarily secured in a bath; and used to lift and lower a patient in the vertical or reclining position while bathing. Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.

Baxter Healthcare Corp. Nov-06-2013 Dual Luer Lock Cap – Dual Luer Lock CapThe device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds; stopcocks or sets. The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

Hamilton Medical; Inc. Nov-06-2013 Hamilton C2 Ventilator – HAMILTON-C2 Ventilator:Manufactured by Hamilton Medical AGCH-7402 Bonaduz; Switzerland;Imported and distributed by Hamilton Medical; Inc. Reno; NV 89502The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults; pediatrics; infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital. Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.

Vital Images; Inc. Nov-06-2013 VitreaCore¿ software – VitreaCore¿ software. Versions subject to the limitation:6.0; 6.1; 6.2; 6.3 (except 6.3.1 ); 6.4 (except 6.4.4 and 6.4.5); aswell as their upgrades; and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process; analyze; review; and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT; MR; CR/DR/DX; SC; US; NM; PET; XA; and RF; etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography. Vital Images; Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0; 6.1; 6.2; 6.3 (except 6.3.1); 6.4 (except 6.4.4 and 6.4.5); as well as their upgrades; and 6.5.

St. Jude Medical Nov-06-2013 US Safire Duo Ablation Catheter MediGuide Enabledand Cool Path Duo Ablation Catheter; MediGuide Enab – US Safire Duo Ablation Catheter MediGuide Enabled; REF A700240 and Cool Path Duo Ablation Catheter; MediGuide Enabled REF A700244; Rx only; Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy. St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).

Steris Corporation Nov-06-2013 Harmony Equipment Management System; Model #603X/80XX; STERIS Corporation; Mentor; OH – Harmony Equipment Management System; Model #603X/80XX; STERIS Corporation; Mentor; OHHarmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses; electrical power and audio/visual data services; in addition to managing surgical support equipment such as endoscopic equipment; cautery devices and insufflators. Dr?ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit; a component of the Harmony EMS system. The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. Should a break occur in the drive screw; there is potential for the adjustable arm to drop down; causing the EMS sys

Carestream Health Inc. Nov-07-2013 DRX-Mobile Retrofit Kit – CARESTREAM DRX -Mobile Retrofit Kit; Catalog number: 1019397. Made in U.S.A. by Carestream Health; Inc. 150 Verona Street Rochester; NY 14608to perform radiographic x-ray examinations on all pediatric and adult patients Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray; DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

Carestream Health Inc. Nov-07-2013 DRX Revolution Mobile X-ray System – DRX- Revolution; Catalog number: 101937; 1023415 & 1023423. Made in U.S.A. by Carestream Health; Inc. 150 Verona Street Rochester; NY 14608to perform radiographic x-ray examinations on all pediatric and adult patients Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray; DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

Pinook-Usa Nov-07-2013 Pinook Mini Massager – Pinook Mini Massager Distributed by www.pinookusa.com.Used to strengthen the abdominal muscles. Failure to submit a premarket submission and gain approval of a medical device.

Pinook-Usa Nov-07-2013 Pinook Mini Massager – Pinook Micro Massager Distributed by www.pinookusa.comUsed to strengthen the abdominal muscles. Failure to submit a premarket submission and gain approval of a medical device.

Mesa Laboratories; Inc. Nov-07-2013 pH 7.0 Buffer Solution – pH 7.0 Buffer Solution Pint and Quart Bottles; Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only).Used in the hemodialysis setting to calibrate pH meters. Mesa Laboratories; Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth.

Siemens Healthcare Diagnostics; Inc. Nov-07-2013 Emit 2000 Phenobarbital Assay and Syva Emit 2000 – Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay Imprecision with certain lots

SEPPIM SAS Nov-07-2013 Calcium Arsenazo; CALA-0250 – Calcium Arsenazo; CALA-0250; For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO; CALA-0250; R: 12×20 mL. The vial's label shows CALCIUM ARSENAZO; CALA-5220; 20 mL; .CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease; a variety of bone diseases; chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting. Calcium Arsenazo Reagent; reference CALA-0250; is recalled due to complaint of plasma specimens report high results than serum.

Baxter Healthcare Corp. Nov-08-2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library – SIGMA SPECTRUM Infusion Pump with Master Drug Library.Intended to be used for the controlled administration of intravenous fluids. Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

St. Jude Medical Nov-08-2013 Safire Duo Ablation Catheter MediGuide Enabled – Safire Duo Ablation Catheter MediGuide Enabled; REF A700240 and A700238; Rx only; Sterile EO.Intended for creating endocardial lesions during cardiac ablation procedures (mapping; stimulation and ablation) for the treatment of typical atrial flutter. St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.

Fresenius Medical Care Holdings; Inc. Nov-08-2013 2008K@ Home Blood lines Combiset True Flow Series – 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis useCatalog Number: 03-2962-3.Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Fresenius Medical Care Holdings; Inc. Nov-08-2013 Combiset Blood Line with BVM – Combiset Blood Line with BVM for Hemodialysis useCatalog Number: 03-2965-9.Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Fresenius Medical Care Holdings; Inc. Nov-08-2013 Combiset Blood Line – Combiset Blood Line Hemodialysis useCatalog Number: 03-2622-3.Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Advanced Sterilization Products Nov-08-2013 STTERRAD 100NX Sterilizer – Sterrad 100NX; Product Code: 10104.Used to sterilize heat and moisture sensitive reusable medical devices. Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers; and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.

Spacelabs Healthcare; Llc Nov-08-2013 Spacelabs Healthcare elance Vital Signs Monitor; Model 93300; with Option S – Spacelabs Healthcare elance Vital Signs Monitor; Model 93300; with Option S. It is a patient monitor with arrhythmia detection or alarms. Spacelabs Healthcare elance Vital Signs Monitor with Option S; model 93330; is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

Terumo Cardiovascular Systems Corporation Nov-08-2013 Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange – Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange; angled tip; wire-reinforced with luer port; aortic cannula; 8.0 mm (24 Fr) OD with 3/8" connector; 14" (36 cm) long.Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During an in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow? Aortic Cannulae and Sarns" Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation Nov-08-2013 Sarns" Venous Return Cannulae – Sarns" Venous Return Cannulae; 20 Fr with 1/4" flare; 14.5" (37 cm) long.Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava. During an in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow? Aortic Cannulae and Sarns" Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation Nov-08-2013 Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange – Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange; straight tip; wire-reinforced with luer port; aortic cannula; 8.0 mm (24 Fr) OD with 3/8" connector; 14" (36 cm) long.Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During an in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow? Aortic Cannulae and Sarns" Venous Return Cannulae.

Terumo Cardiovascular Systems Corporation Nov-08-2013 Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange – Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange; straight tip; wire-reinforced with luer port; aortic cannula; 7.0 mm (21 Fr) OD with 3/8" connector; 14" (36 cm) long.Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. During an in-process inspection; Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow? Aortic Cannulae and Sarns" Venous Return Cannulae.

Urologix; Inc. Nov-08-2013 Prostiva RF Therapy Hand Piece Kit – Prostiva RF Therapy Hand Piece Kit; REF 8929; Rx only; sterilized using Ethylene Oxide.The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the system provides selective thermal ablation of prostate tissue to help reduce urethralconstriction and relieve BPH voiding symptoms.The Prostiva RF Therapy System consists of the following major components:" Radio Frequency Generator" Hand Piece Kit" TelescopeThe Model 8929 Prostiva RF Therapy Hand Piece Kit contains the following single-use; disposable components:" One sterile Hand Piece with radiofrequency cable (Model 8929)" One sterile Tubing System (Model 6101)" One non-sterile Return Electrode (Model 8934)The hand piece has two insulated electrode needles that deliver the radio frequency energy interstitially to the prostate. These needles are covered by insulating shields that localize the lesions within the prostate; protect the urethra from thermal damage; and eliminate collateral thermal damage. The Hand Piece stainless steel (SS) tube is inserted into the urethral canal up to the prostate with the aid of a telescope for visualization during the therapy. The Hand Piece features two insulated Nitinol needles inside the SS tube. The needles can be deployed (extended); at approximately a 90-degree angle from the SS tube; to a preset depth of between 12 mm and 22 mm (at 2 mm intervals). The needles inside the SS tube are deployed into; or retracted from the prostate; using the handle lever. RF energy is delivered through the needles to the prostate tissue. The RF energy creates molecular friction eventually resulting in tissue heating and cell death (therapy intent). Urologix is voluntarily recalling Prostiva RF Therapy Hand Piece Kits; Part Number 8929; Lot Number 215251 due to a Hand Piece not meeting an in-process force test specification.

Baxter Healthcare Corp. Nov-08-2013 Sigma Spectrum Infusion Pump component (LCD screen) – SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen; 55074-2 revision B)Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs; blood; blood products and mixtures of required patient therapy. Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.

DePuy Mitek; Inc.; a Johnson & Johnson Co. Nov-08-2013 DePuy Mitek FMS Outflow Tubing with One-Way valve – DePuy Mitek FMS Outflow Tubing with One-Way valveProduct Code:284649Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath; clamps; and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy. Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination

DePuy Mitek; Inc.; a Johnson & Johnson Co. Nov-08-2013 DePuy Mitek FMS Intermediary Tubing with One-Way valve – DePuy Mitek FMS Intermediary Tubing with One-Way valveProduct Code: 281142 Product Usage:The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath; clamps; and a one-way valve. The FMS Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy. Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE; WORKGROUP – Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE; WORKGROUPThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual Access Plus SW; Workgroup – Carestream Vue PACS; Virtual Access Plus SW; WorkgroupThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual PWR Reading Basic SW; Workgroup – Carestream Vue PACS; Virtual PWR Reading Basic SW; WorkgroupThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual PWR Reading Basic SW; 8 Pack – Carestream Vue PACS; Virtual PWR Reading Basic SW; 8 PackThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup – Carestream Vue PACS; Virtual PWR Reading Basic SW WorkgroupThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack – Carestream Vue PACS; Virtual PWR Reading Basic SW 8 PackThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual Access Software; StandAlone – Carestream Vue PACS; Virtual Access Software; StandAloneThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual Access Pluse SW; StandAlone – Carestream Vue PACS; Virtual Access Pluse SW; StandAloneThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual Enterprise SW StandAlone – Carestream Vue PACS; Virtual Enterprise SW StandAloneThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone – Carestream Vue PACS; Virtual PWR Reading Basic SW StandAloneThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Virtual Reading Basic SW StandAlone – Carestream Vue PACS; Virtual Reading Basic SW StandAloneThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR – Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR – Carestream Vue PACS; Unlimited Reading LIC<15K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y – Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/YThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR – Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR – Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR – Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR – Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR – Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE – Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSEThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING – Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWINGThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW – Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEWThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT – Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINTThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC – Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LICThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR – Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR – Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YRThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS – Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMSThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC – Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LICThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC – Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LICThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC – Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LICThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC – Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LICThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC – Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LICThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Carestream Health Inc. Nov-13-2013 Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED – Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITEDThe CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites; which will archive; distribute; retrieve and display images and data from all hospital modalities and information systems. Carestream Health; Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions; some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

Siemens Medical Solutions USA; Inc Nov-13-2013 Siemens syngo.plaza – Siemens syngo.plaza image processing systemimage processing radiological system The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.

Synthes USA HQ; Inc. Nov-13-2013 Synthes 8.5 MM Medullary Reamer – Synthes 8.5 MM Medullary Reamer Product Usage:An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue; or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier; awl; bender; drill brace; broach; bmT; corkscrew; countersink; pin crimper; wire cutter; prosthesis driver; extractor; file; fork; needle holder; impactor; bending or contouring instrument; compression instrument; passer; socket positioner; probe; femoral neck punch; socket pusher; reamer; rongeur; scissors; screwdriver; bone skid; staple driver; bone screw starter; surgical stripper; tamp; bone tap; trephine; wire twister; and wrench. Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.

Philips Healthcare Informatics; Inc. Nov-13-2013 IntelliSpace PACS – Philips brand IntelliSpace PACS 4.4; Image Management System; The system is a software package used with general purpose computing hardware to acquire; store; distribute; process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics; Inc. Foster City; CAIntelliSpace PACS are image management systems intended to be used by trained professionals; including but not limited to physicians; nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire; store; distribute; process and display images and associated data throughout a clinical environment. The software performs digital image processing; measurement; communication and storage. iSite supports receiving; sending; printing; storing and displaying studies received from the following modality types via DICOM: CT; MR; NM; US; XA; PET; DX; DR; RE; RT; MG; SC; VL; as well as hospital/radiology information systems. Philips Healthcare became aware of a software problem with the IntelliSpace PACS system; in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.

Integra LifeSciences Corp. Nov-13-2013 MAYFIELD¿ Composite Series Skull Clamp – Composite Series Skull Clamp; one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device; designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury; adverse health consequence; or a delay / prolongation of the surgical procedure.

GE Healthcare; LLC Nov-13-2013 AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.); AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ O – AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.); AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION); AW Server.K052995: Advantage Workstation 4.3 is a review station; which allows easy selection; review; processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician; filmed or displayed images on the AW monitor may be used as a basis for diagnosis; except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation; which allows easy selection; review; processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician; filmed or displayed images on the AW monitor may be used as a basis of diagnosis; except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking; selection; processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products.The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc

Nobel Biocare Usa Llc Nov-13-2013 Osseocare Pro Console & Set Osseocare Pro – Osseocare Pro Console & Set Osseocare Pro; Model 1600870-001; 1700470-001; and 1700471-001.Device Name: Osseocare Pro console & Set Osseocare Pro.Model: 1600870-001; 1700470-001; 1700471-001.Marketing status: Class I; under K092214.Device description: Software-based; electronically controlled tabletop device.In dentistry for dental surgery; endodontics and implantology. The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.

Toshiba American Medical Systems Inc Nov-13-2013 Vantage Titan 3T MRI System; MRT-3010A/5 – Titan 3T MRI System; MRT-3010A/5.Product Usage: Usage:MRI system. Toshiba America Medical Systems; Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR)values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large KneeSPEEDER (MJAJ-182A); SAR values lower than the actual SAR values may be displayed on the operatingmonitor.

GlaxoSmithKline; LLC. Nov-13-2013 Biotene Moisturizing Mouth Spray – Biotene Moisturizing Mouth Spray; with xylitol; For dry mouth symptom relief; 44.3ml/1.5 FL. OZ.; Sugar Free Sweetened with xylitol and sorbitol; GlaxoSmithKline; Consumer Healthcare; L.P.; Moon Township; PA 15108.Biotene Mouth Spray is used for the treatment of dry mouth Label indicates; "Sweetened with xylitol and Sorbitol"; however product does not contain sorbitol.

The Anspach Effort; Inc. Nov-13-2013 BlackMax Motor Systems; MicroMax Motor Systems; XMax Motor Systems; EMax2 Motor Systems; Emax2Plus M – Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems; XMax Motor Systems; EMax2 Motor Systems; and Emax2Plus Motor Systems; all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone Anspach Effort; Inc. Palm Beach Gardens; FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual; Cutting Burr Chart and Product Catalog.

The Anspach Effort; Inc. Nov-13-2013 BlackMax Motor Systems; MicroMax Motor Systems; XMax Motor Systems; EMax2 Motor Systems; Emax2Plus M – Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems; MicroMax Systems and XMax Motor Systems all models and serial numbers.Product Usage:Indication for use is cutting and shaping bone. Anspach Effort; Inc. Palm Beach Gardens; FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual; Cutting Burr Chart and Product Catalog.

The Anspach Effort; Inc. Nov-13-2013 BlackMax Motor Systems; MicroMax Motor Systems; XMax Motor Systems; EMax2 Motor Systems; Emax2Plus M – Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems; XMax Motor Systems; EMax2 Motor Systems; and Emax2Plus Motor Systems; all models and serial numbers.Product Usage: Indication for use is cutting and shaping bone. Anspach Effort; Inc. Palm Beach Gardens; FL is initiating a medical Device labeling correction for its Pneumatic Systems Operating Manual; Cutting Burr Chart and Product Catalog.

DeRoyal Industries Inc Nov-14-2013 DeRoyal (R) Surgical Eye Spears – DeRoyal (R) Surgical Eye Spears; REF 30-049; Sterile EO; Manufacturer: DeRoyal Industries; Inc. 200 DeBusk Lane; Powell; TN 37849; MADE IN GUATEMALAcleaning of fluids from surgical site in or near the eye One lot of eye spears was labeled as being x-ray detectable; but contained non x-ray detectable product.

OrthoPediatrics Corp Nov-14-2013 3.5MM LOCKING SCREW; T15 HEXALOBE; SELF TAPPING; 34MM – 3.5MM LOCKING SCREW; T15 HEXALOBE; SELF TAPPING; 34MMThe OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system. The firm identified; through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation; it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.

SpineFrontier; Inc. Nov-14-2013 S-LIFT Extension Shims – S-LIFT Extension ShimsExtension shims are manufactured from grade 5 titanium and are curved; rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties; either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades; and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field. Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades.

Siemens Medical Solutions USA; Inc Nov-14-2013 Siemens Artis zee systems – Artis zee systemsx-ray; angiographic system The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135; 10094137; and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – Plum A+ Infusion Pump; List Number: 11971; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – Plum A+ Infusion Pump; List Number: 12618; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – Plum A+ Infusion Pump; List Number: 11973; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – Plum A+ Infusion Pump; List Number: 12391; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Hospira Inc. Nov-14-2013 Plum A+3 Infusion Pump System – Plum A+3 Infusion Pump System; List Number: 12348; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Hospira Inc. Nov-14-2013 Plum A+ Hyperbaric Infusion Pump – Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage:The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180; E181/N181; E186/N186; E187/N187 or E346. Additionally; if the pressure sensor calibration has drifted; users may experience false distal occlusion alarms or distal occlusions that may not

Medtronic Neuromodulation Nov-14-2013 RestoreUltra and RestoreSensor – Medtronic RestoreUltra; model 37712; and RestoreSensor; model 37714; Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

Medtronic Neuromodulation Nov-14-2013 Activa PC; Activa RC; Active SC – Medtronic Activa PC; model 37601; and Activa RC; model 37612; Activa SC; models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

Draeger Medical; Inc. Nov-14-2013 Draeger Movita 603x/DVE 803x Ceiling Supply Unit – Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches).

Zimmer; Inc. Nov-14-2013 VerSys¿ Cemented Revision Calcar (CRC) Hip System – VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral StemsVerSys Heritage Hip System Revision Femoral Stems.Indicated for total hip arthroplasty. Based on a review of historic packaging validations; it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid

RAYSEARCH LABORATORIES AB Nov-14-2013 RayStation – Ray Station Radiation Therapy Treatment Planning System; Model Numbers 3.0; 3.5 and 4.0 Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0; 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

Stryker Instruments Div. of Stryker Corporation Nov-14-2013 Acetabular Pressurizer 0206-522-000 – Acetabular Pressurizer; single use and six units per box.The Acetabular Pressurizer 0206-522-000 is an accessory to theAdvanced Cement Mixer (ACM). The Acetabular PressurizerTiplet P/N 0206-522-012 is sealed in a two pouches; sterilized; and labeled as part number 0206-522-000.This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded. On March 14; 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15; 2013; when the product was going to be placed in the pouch to be sealed; the manufacturing operator noticed that some assemblies were cracked. As a result of the injection pressure of the cement gun; a cracked tiplet may release from the Hub during cement applica

Beckman Coulter Inc. Nov-14-2013 Access 2 Immunoassay System – Access 2 Immunoassay System; Part Number: 81600NThe Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

Hospira Inc. Nov-14-2013 Plum A+3 Infusion Pump System – The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+3 Infusion Pump – The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+3 Infusion Pump with Hospira MedNet Software – The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump with Hospira MedNet Software – The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+ Hyperbaric Infusion Pump – The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Hospira Inc. Nov-14-2013 Plum A+ Infusion Pump – The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard; piggyback; or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral; enteral; or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser; disposable IV sets (hereafter called a set); optional accessories; and this operator's manual.The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral; enteral and epidural therapies and the administration of whole blood and blood products. Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only by detected via a visual inspection of the distal pressure pin. A broken

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products ACET Slides – VITROS Chemistry Products ACET Slides; 90 slides/pack; catalog number 1037274VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products AcP Slides – VITROS Chemistry Products AcP Slides; 90 slides/pack; catalog number 8168122VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products ALB Slides – VITROS Chemistry Products ALB Slides; 90 slides/pack; catalog number 1988211VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products ALC Slides – VITROS Chemistry Products ALC Slides; 90 slides/pack; catalog number 8046872VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products ALKP Slides – VITROS Chemistry Products ALKP Slides; 300 slides/pack; catalog number 1053180VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products AMON Slides – VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products AMYL Slides – VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products AST Slides – VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products BuBc Slides – VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products BUN/UREA Slides – VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration; reported either as urea nitrogen (BUN) or as urea (UREA); in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products Ca Slides – VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CHE Slides – VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CHOL Slides – VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CK Slides – VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CK-MB Slides – VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CRBM Slides – VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382 Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CREA Slides – VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products CRP Slides – VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products DGXN Slides – VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products dHDL Slides – VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products ECO2 Slides – VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products Fe Slides – VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products GLU Slides – VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum; plasma; urine and cerebrospinal fluid using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products LAC Slides – VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products Li Slides – VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products LIPA Slides – VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products Mg Slides – VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products PHBR Slides – VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products PHOS Slides – VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products PHYT Slides – VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products PROT Slides – VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products SALI Slides – VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products TBIL Slides – VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products THEO Slides – VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products TRIG Slides – VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products UPRO Slides – VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Ortho-Clinical Diagnostics Nov-15-2013 VITROS Chemistry Products URIC Slides – VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

GE Healthcare It Nov-15-2013 Centricity Laboratory Core Lab – The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities; e.g.; the storing and delivering of analytical results. It is a specially designed data program application (software); which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run; steer; or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities; including a central laboratory or in a multiple laboratory environment servicing satellite laboratories; reference laboratories; clinics; etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical; anatomic pathology and cytology laboratory workflow such as order entry; results entry; instrument interfacing; results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists; technicians; analyst and other trained/site authorized system users GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel; and; 2) The panitem specimen group field of one or more of the ordered items on the ma

Carl Zeiss Meditec; Inc. Nov-15-2013 IOLMaster – Zeiss brand IOLMaster; Version 1-5; Biomicroscope; Slit-Lamp; AC-Powered; Product is manufactured by Carl Zeiss Meditec AG (Jena);Carl Zeiss Promenade 10; Jena; Germany 07745; and distributed by Carl Zeiss Meditec; Inc.; Dublin; CAThis device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length; anterior chamber depth; corneal radius; white-to white (WTW); and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation; the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.

Carl Zeiss Meditec; Inc. Nov-15-2013 IOLMaster 500 – Zeiss brand IOLMaster 500; Model 500; Biomicroscope; Slit-Lamp; AC-Powered; Product is manufactured by Carl Zeiss Meditec AG (Jena);Carl Zeiss Promenade 10; Jena; Germany 07745; and distributed by Carl Zeiss Meditec; Inc.; Dublin; CAThis device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length; anterior chamber depth; corneal radius; white-to white (WTW); and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation; the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.

Olympus America Inc. Nov-15-2013 Olympus Endoscopic Flushing Pump; Model OPF-2 – Olympus Endoscopic Flushing Pump; Model OPF-2.Facilitates washing of tissues to remove blood; feces and other organic matter during endoscopic procedures. There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may; under certain circumstances; cause the pump to stop and go into power stand-by mode.

Philips Medical Systems (Cleveland) Inc Nov-15-2013 Brilliance iCT Computed Tomography X-Ray System; – Brilliance iCT Computed Tomography X-Ray System; Product Usage:The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. If the couch; with the footrest extension attached; is positioned where the table travel is within the bore of the gantry; and the user begins to lower the couch; the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.

ConMed Corporation Nov-15-2013 ALTRUS – ALTRUS¿ THERMAL TISSUE FUSION; Tissue Fusion Handpiece; 5 mm O.D.; 16 cm Shaft; REF 60-9520-001; STERILE — CONMED CORPORATION 525 FRENCH RD; UTICA; NY 13502 — The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus¿ System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus¿ Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing; grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas. The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor; local; self correcting infection.

ConMed Corporation Nov-15-2013 ALTRUS – ALTRUS¿ THERMAL TISSUE FUSION; Tissue Fusion Handpiece; 5 mm O.D.; 36 cm Shaft; REF 60-9522-001; STERILE — CONMED CORPORATION 525 FRENCH RD; UTICA; NY 13502 — The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus¿ System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus¿ Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing; grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas. The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor; local; self correcting infection.

Terumo Cardiovascular Systems Corporation Nov-18-2013 Vascutek Gelsoft – Vascutek Gelsoft Vascular Graft (peripheral)Labeling reads in part; "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan; Renfrewshire PA4 9RR Scotland***"The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed; woven polyester graft indicated for abdominal and peripheral vascular repair; i.e. replacement or bypass in aneurysmal and occlusive disease of arteries Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.

Riverpoint Medical; LLC Nov-18-2013 Polyglycolic-Lactic Acid Absorbable Surgical Suture – Polyglycolic-Lactic Acid Absorbable Surgical SutureLabel reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***"PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation; including use in opthalmic procedures; but not for use in cardiovascular and neurological tissues Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

Candela Corporation Nov-18-2013 Candela Laser – Candela Laser GentleLase Pro; Powered Laser Surgical Instrument for dermatological use – Model number: 9914-00-9015.and Candela Laser GentleLase Pro LE; Model number: 9914-00-9040 Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

Synthes USA HQ; Inc. Nov-18-2013 Synthes Soft Tissue Retractor Small Extendible – Synthes Soft Tissue Retractor Small ExtendibleOffset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.

Trumpf Medical Systems; Inc. Nov-18-2013 TruSystem – TruSystem Surgical Table (TS7000)  Leg Section One Part Light HUUse of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000; in conjunction with operating table components is intended for the use of patient positioning during surgery; ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery. The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.

Spacelabs Healthcare; Llc Nov-18-2013 Spacelabs Healthcare qube Compact Patient Monitor; Model 91390 – Spacelabs Healthcare qube Compact Patient Monitor; Model 91390. It is a patient monitor with arrhythmia detection or alarms.The qube is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high; medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. Spacelabs Healthcare qube Compact Patient Monitor; Model 91390; may fail to power ON due to incorrect programmed microcontroller component.

GE Healthcare It Nov-18-2013 Centricity Perinatal and Centricity Intensive Care – Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery; Postpartum Maternal Care; newborn Nursery; critical care units including Neonatal Intensive Care Units (NICU); and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept; transfer; display; calculate; store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document; annotate; display; store; print; export and retrieve patient clinical practice information. This product is intended for professional use only. 1) Under rare network conditions; a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When

Siemens Healthcare Diagnostics Nov-18-2013 ADVIA 1200 System Software: 1) V2.00; 2) V2.01 – ADVIA 1200 System Software: 1) V2.00; 2) V2.01.Performs assays for general and specialty chemistries; methods for specific protein measurement; drugs-of-abuse testing and therapeutic drug monitoring. Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200; 1650; 1800 or 2400 Chemistry Systems.

Stryker Sustainability Solutions Nov-18-2013 Eletrophysiology Catheter; BARD;Daig;BW CristaCath;Response;Supreme;Qwik Cable;BW Webster; Carto 3 – Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables; Model Numbers: D6-DR-252-RT; F6-QF-252RT; 201101; 201104; 401442; 401860; D7-A20-131-RT; 401661; 401972; 401977; 401981; 401982; C6-MR/MST4-SA; CB3434CT.Product Usage: Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing; recording; stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies. Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

Siemens Healthcare Diagnostics Nov-18-2013 ADVIA 1650 System Software: 1) V4.01; 2) V3.52 – ADVIA 1650 System Software: 1) V4.01; 2) V3.52.Performs assays for general and specialty chemistries; methods for specific protein measurement; drugs-of-abuse testing and therapeutic drug monitoring. Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200; 1650; 1800 or 2400 Chemistry Systems.

Siemens Healthcare Diagnostics Nov-18-2013 ADVIA 180 System Software V2.01 – ADVIA 1800 System Software V2.01.Performs assays for general and specialty chemistries; methods for specific protein measurement; drugs-of-abuse testing and therapeutic drug monitoring. Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200; 1650; 1800 or 2400 Chemistry Systems.

Siemens Healthcare Diagnostics Nov-18-2013 ADVIA 2400 System Software V4.01 – ADVIA 2400 System Software V4.01.Performs assays for general and specialty chemistries; methods for specific protein measurement; drugs-of-abuse testing and therapeutic drug monitoring. Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200; 1650; 1800 or 2400 Chemistry Systems.

Zimmer; Inc. Nov-18-2013 Trinica Anterior Lumbar Plate (ALP) system – Trinica Anterior Lumbar Plate (ALP) system; part 07.01058.001. Non Sterile; Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally; this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V).The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach; below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation); tumor; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudoarthrosis; spondylolisthesis; scoliosis; lordotic deformities of the spine; spinal stenosis; or a failed previous fusion. Zimmer Spine; Inc. is initiating a correction regarding the Trinica ALP Instrument Tray; part 07.01058.001 (all lots). The Ratchet Handles; part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.

Synovis Surgical Innovations; Inc. Nov-18-2013 Dura-Guard Dural Repair Patch – Dura Guard; Dural Repair Patch with Apex Processing.For use as a dura substitute for the closure of dura mater during neurosurgery.Product Code:DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN Synovis; a subsidiary of Baxter International Inc.; is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis; a subsidiary of Baxter International Inc.; is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping

Synovis Surgical Innovations; Inc. Nov-18-2013 Vascu Guard Peripheral Vascular Patch – Vascu Guard; Peripheral Vascular Patch with Apex Processing.For use in peripheral vascular reconstruction.Product Code:VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N Synovis; a subsidiary of Baxter International Inc.; is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis; a subsidiary of Baxter International Inc.; is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping

Restoration Robotics Nov-18-2013 ARTUS system Disposable Kit – ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384;Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts; Reusable Kit FP 45538Rx):Product Usage:Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue hasbeen identified as a compound of iron and chlorine.

Restoration Robotics Nov-18-2013 Sterile Disposable Kit – Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117; follicle Trap PRT 23999):Product Usage:Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue hasbeen identified as a compound of iron and chlorine.

Restoration Robotics Nov-18-2013 Computer assisted hair harvesting system accessory – Epsilon Skin Tensioner:Rx; SterileSterilized using Gamma. Turns Red if sterilized using Gamma;Product Usage:Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue hasbeen identified as a compound of iron and chlorine.

Restoration Robotics Nov-18-2013 ARTAS System Disposable kit – ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap – FP-23306 and Non-sterile Disposable Clinical Kit FP -23267):and ARTAS Disposable Kits; 18 Gauge Epsilon (Contains Disposable Kit; 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267).RX. Product Usage:Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue hasbeen identified as a compound of iron and chlorine.

Ebi; Llc Nov-19-2013 Polaris Translation Screw System – BIOMET Spine; Parsippany; NJ 07054. 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile.Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

Stryker Medical Division of Stryker Corporation Nov-19-2013 Rose Bed – Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails It was reported that the siderail may appear latched when it is not; due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally; the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.

SALTER LABS Nov-19-2013 Salter Labs EtCO2 Sample line – Salter Labs EtCO2 Sample line 15′ (4.6 M) tube; male luer connectors.Rx only; Made in Mexico; Manufacturer:Salter Labs; 100 West Sycamore Road;Arvin; CA 93203.CO2 sample line. It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15′ tube; male Luer lock connectors may contain a 30′ tube instead of the 15′ length.

Biomet; Inc. Nov-19-2013 Juggerknotless Soft Anchors – Juggerknotless Drill Bit; REF 110003173; Sterile; Single UseProduct Usage:The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder; foot/ankle; hand/wrist; and hip. Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.

Wexford Labs Inc Nov-19-2013 Ready To Use Thymo-Cide – Ready to Use Thymo-Cide; Germicidal Detergent; containing 0.051% thymol; packaged in 1-qt. bottles. The firm name on the label is Wexford Labs; Inc.; Kirkwood; MO.For disinfection of hard; non-porous surfaces (floors; walls; tables; etc.) in operating rooms; intensive care; nurseries; emergency areas; dental operatories; police; EMS; and all health care facilities. Expired active ingredient was used in the manufacture of the product.

Aesculap; Inc. Nov-19-2013 Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020R-US) – Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.

Ossur North America Inc Nov-19-2013 Fixed Offset Adapter; A-642100 – Fixed Offset Adapter; A-642100.The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14;5mm (0.57inch). Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.

Siemens Healthcare Diagnostics Nov-19-2013 Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent – Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent; Siemens Material Number (SMN) 10312279; REF 09784096; Part Number T03-1291-62; IVD Product usage: Usage:DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200; 1650; 1800; and 2400 Chemistry Systems. The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of

Ergosafe Products LLC DBA Prism Medical Services USA Nov-20-2013 Medcare Products Max-500 Stand; Total Support – Medcare Products Max-500 Stand; Total Support; patient stand; model #400006. The responsible firm name listed in the Operations Manual is Medcare Products; Burnsville; MN.Used for assisting patients/residents to a standing position. The lift might fail with the labeled 500-lb. load rating.

Ergosafe Products LLC DBA Prism Medical Services USA Nov-20-2013 Medcare Products Max-500 Stand; Total Support – Medcare Products Max-500 Stand-N-Weigh; Total Support; patient stand; model #400007. The responsible firm name listed in the Operations Manual is Medcare Products; Burnsville; MN.Used for assisting patients/residents to a standing position. The lift might fail with the labeled 500-lb. load rating.

Hospira Inc. Nov-20-2013 SYMBIQ One-Channel and Two-Channel Infusers – *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser;*** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery.Symbiq is a general-purpose infuser designed to deliver fluids; solutions; medications; agents; nutritionals; electrolytes; blood and blood products for parenteral; enteral; intra-arterial; subcutaneous; or irrigation routes of administration. Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.

Synthes USA HQ; Inc. Nov-20-2013 Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade – Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical BladeSynthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures; intertrochanteric fractures; basal neck fractures; and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures; pertrochanteric fractures associated with shaft fractures; pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions; long subtrochanteric fractures; proximal or distal non-unions; malunions; and revisions. A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

GE Healthcare; LLC Nov-20-2013 GE Healthcare Discovery NMCT 670; Discovery NM 630; Optima NMCT 640; & Brivo NM 615 – GE Healthcare Discovery NMCT 670; Discovery NM 630; Optima NMCT 640; & Brivo NM 615.The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting; localizing; diagnosing of diseases and organ function for the evaluation of diseases; trauma; abnormalities; and disorders such as; but not limited to; cardiovascular disease; neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; planning; guiding; and monitoring therapy. The GE Discovery NM/CT 670 system; combining Nuclear Medicine (NM) and Computed Tomography (CT) systems; is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static; Multi-gated; Dynamic and Whole body scanning) and tomographic mode (SPECT; Gated SPECT; Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators; gating by physiological signals; and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes; including Axial; Cine; Helical; Cardiac; and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head; whole body; cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined; hybrid SPECT and CT protocols; for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization; registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment; patient and equipment supports; components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images; imaging planes; and analysis results. The system may be used for patients of all ages. The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting; localizing; diagnosing of diseases and in assessment of organ function for the evaluation of diseases; trauma; abnormalities; and disorders such as; but not limited to; cardiovascular disease; neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; planning; guiding; and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system; which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static; Multi-gated; Dynamic and Whole body scanning) and tomographic mode (SPECT; Gated SPECT; Whole body SPECT). The acquisition types include single and multi isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators; gating by physiological signals; and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment; patient and equipment supports; components and accessories. The system may be used for patients of all ages. – The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scann GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging.Contact between the Detector (GE Healthcare Discovery NM/CT 670; and/or Optima NM/CT 640; and/or DiscoveryNM630; and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a

Teleflex Medical Nov-20-2013 Green Rusch-Lite Disposable Metal Larynogoscope Blade. – Green Rusch – Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube. Labeling inconsistency

Philips Medical Systems North America Inc. Nov-20-2013 EPIQ 7 Ultrasound System – EPIQ 7 Ultrasound System; Model 795200; 795201; 795202.Intended for diagnostic ultrasound imaging and fluid flow analysis. A problem has been detected with Philips Model EPIQ 7 Ultrasound System; software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).

Stryker Spine Nov-21-2013 Stryker Spine Torque Wrench – Stryker1) XIA Torque Wrench2) XIA 3 Torque Wrench3) XIA Elegance Short Torque WrenchManufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30http://www.stryker.comDistributed in the USA by: Stryker Spine 2 Pearl Court Allendale; NJ 07401-1677 USA +1-201-760-8000XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior; non cervical pedicle and on-pedicled fixation system; the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA – Intended for anterior/anterolateral and posterior; non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis; trauma; spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.

Ivoclar Vivadent; Inc. Nov-21-2013 Excite F. DSC – ExciTE F DSC Soft touch Single Dose; Dual-curing Regular Ref. 50 dental adhesive for restorations Ivoclar Vivadent; Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

GE Healthcare; LLC Nov-21-2013 Vivid E9 ultrasound system – GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system; which is primarily intended for cardiac imaging and analysis; but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear; curved linear; sector/phased array or matrix array format; including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel; LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up; with the result that the vivid E9 Scanner must be rebooted.

Southern Implants; Inc Nov-22-2013 Tri-Nex Healing Abutment – Tri-Nex Healing Abutment; 0.50 mm x 5 mm height; Catalog No. HA-L-50-5.The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth; partially edentulous prostheses; or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading; to restore chewing function. Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment; 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5).

Synthes USA HQ; Inc. Nov-22-2013 Synthes Matrix Threaded Persuader – Synthes Matrix Threaded PersuaderDeformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges. Synthes became aware that during a procedure using the Matrix Threaded Persuader; the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.

Biomet; Inc. Nov-22-2013 Security Enclosed Carpal Tunnel Security Blade – REF 200068 Security (TM) Enclosed Carpal Tunnel SystemBlade ( Single) ABS /Stainless SteelSterile Device; Single Use Only. Designed to release the transverse carpal ligament. Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.

Synthes USA HQ; Inc. Nov-22-2013 Synthes 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM – 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MMFixation of fractures; osteotomies; nonunions; replantations; and fusions of small bones and small bone fragments; particularly in osteopenic bone. Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

Mizuho America; Inc. Nov-22-2013 Mizuho Sugita Titanium Standard Aneurysm Clip II – Temporary Mini Type No 56 – Mizuho Sugita Titanium Standard Aneurysm Clip II ; Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use. Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type; are discolored.

Mizuho America; Inc. Nov-22-2013 Mizuho Sugita Titanium Standard Aneurysm Clip II ; Temporary Mini Type No 58 – Mizuho Sugita Titanium Standard Aneurysm Clip II ; Temporary Mini Type No 58Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use. Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type; are discolored.

Roche Diagnostics Operations; Inc. Nov-22-2013 ACCU-CHEK – ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases; when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter; there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.

Synthes USA HQ; Inc. Nov-25-2013 Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN – Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures; intertrochanteric fractures; basal neck fractures; and combinations there of. The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

Mindray DS USA; Inc. dba Mindray North America Nov-25-2013 V Series Monitor; Mindray DS USA; Inc – Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage:The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3; 5; 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension; potentially causing the screen to temporarily go blank; lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.

Synthes USA HQ; Inc. Nov-25-2013 Synthes Tensioning Device – Synthes Tensioning Device The Synthes Osteogenesis System; MR Conditional is intended for fracture fixation (open and closed); pseudoarthrosis or non-unions of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients. All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release; nor the device to apply tension.

Synthes USA HQ; Inc. Nov-26-2013 Synthes TI MIRS Polyaxial Screw Body; Part Number 04.631.500 – Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body; Part Number 04.631.500Non-cervical spinal fixation devices intended for posterior pedicle screw fixation; posterior hook fixation; or anterolateral fixation. This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening; the potential exists for locking caps to loosen post-operatively in certain situations.

Baxter Healthcare Corp. Nov-26-2013 Baxter; VIAL-MATE Adaptor – Baxter; VIAL-MATE Adaptor; 2B8071; Rx Only; STERILE R; Baxter Healthcare Corporation; Deerfield; IL 30015 USAThe VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL; 100mL; and 250mL Single Pack Mini Bags. Incomplete foil seal on one lot of sterile product.

Synthes USA HQ; Inc. Nov-26-2013 Synthes TI MIRS Locking Cap; One-Step Titanium Alloy; Part Number 04.631.502 – Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap; Part Number 04.631.502Non-cervical spinal fixation devices intended for posterior pedicle screw fixation; posterior hook fixation; or anterolateral fixation. This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening; the potential exists for locking caps to loosen post-operatively in certain situations.

Advanced Sterilization Products Nov-26-2013 STERRAD 100NX – STERRAD 100NX; Product Code: 10104The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

Synthes USA HQ; Inc. Nov-26-2013 Synthes Matrix 5.5.mm Left and Right Coronal Bender – Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane; and is intended for stabilization of the thoracic; lumbar; sacral; and/or iliac spine through screw and/or hook and rod fixation. A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.

Advanced Sterilization Products Nov-26-2013 STERRAD NX – STERRAD NX; Product Code: 10033The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

Synthes USA HQ; Inc. Nov-26-2013 Synthes 3.7mm and 5.0mm Dynamic Locking Screw (DLS) – 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures; the fixation of osteopenic bone; the fixation of osteotomies; and for the fixation of non-unions and malunions. All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.

Lanx; Inc. Nov-26-2013 Timberline MPF Straight Split Tip Driver – Short ("Driver") – LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver – Short ("Driver"). Model Number 8630-0107.The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer; titanium plate; and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae. Lanx; Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver – Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.

Synthes USA HQ; Inc. Nov-26-2013 Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER – Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STERSynthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar; intra-articular and extra articular condylar fractures; periprosthetic fractures; fractures in normal or osteopenic bone; nonunions and malunions. A plate was inadvertently released to a sales consultant that was restricted for sale.

Synthes USA HQ; Inc. Nov-26-2013 Synthes Spiked Washers 13.5/6.5 – Synthes Spiked Washers 13.5/6.5Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation; specifically readaptation of torn or avulsed ligaments. During a retrospective assessment; Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

Siemens Medical Solutions USA; Inc Nov-26-2013 Siemens Rad Fluoro Uro Systems – (Siemens Rad Fluoro Uro Systems) Ysio; Luminos Agile; Luminos dRF; and Uroskop Omnia systems with software version VC10Image intensified fluoroscopic x-ray system A potential malfunction and hazard to patients exists when using the Ysio; Luminos Agile; Luminos dRF; and Uroskop Omnia systems with software version VC10; which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.

Synthes USA HQ; Inc. Nov-26-2013 Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar – Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft; open and closed tibia shaft fractures; certain pre- and post- isthmic fractures; and tibial malunions and non-unions. Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.

Synthes USA HQ; Inc. Nov-26-2013 Synthes Material Mix – Synthes Material Mix (Adjustable Cervical Distractor-Right; Matrix Distractor Rack; T-PAL Spacer Remover; Implant Inserter)Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant. One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

Medtronic Neurosurgery Nov-26-2013 CSF-Unitized Shunt – CSF-Unitized Shunt; Contoured Regular; Low Pressure; Catalog No. 46022;CSF-Unitized Shunt; Contoured Regular; Medium Pressure; Catalog No. 46024; CSF-Unitized Shunt; Contoured Regular; High Pressure;Catalog No. 46026.CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity. Medtronic Neurosurgery is recalling the CSF-Unitized Shunts; Delta Shunt Assembly Kit; and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Medtronic Neurosurgery Nov-26-2013 Medtronic Delta Shunt Assembly Kit with Bioglide Small – Medtronic Delta Shunt Assembly Kit with Bioglide Small; Performance Level 1.0; Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity. Medtronic Neurosurgery is recalling the CSF-Unitized Shunts; Delta Shunt Assembly Kit; and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Medtronic Neurosurgery Nov-26-2013 Medtronic Strata II Shunt Assembly Kit – Medtronic Strata II Shunt Assembly Kit; Small; Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity. Medtronic Neurosurgery is recalling the CSF-Unitized Shunts; Delta Shunt Assembly Kit; and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Synthes USA HQ; Inc. Nov-27-2013 Synthes Slipped Capital Femoral Epiphysis System – Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis; pediatric femoral neck fractures; intercondylar femur fractures and sacroiliac joint disruptions. There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

B. Braun Medical; Inc. Nov-27-2013 B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers; BC2000 – 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers; BC1300Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation; it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector; which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i

Custom Ultrasonics; Inc. Nov-27-2013 Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector – Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.

B. Braun Medical; Inc. Nov-27-2013 B. Braun 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers; BC2000 – 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers; BC2000Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation; it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE(TM) Binary Connector; which pierces the PAB(R) bag stopper to access the solution. The misaligned cannula may result i

Synthes USA HQ; Inc. Nov-27-2013 Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm – Synthes 2.4 mm LC-DCP Plate 6 Holes/51mmProduct Usage: Intended for fractures; osteotomies; and replantations of small bones including the foot; ankle; and hand. A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.

Synthes USA HQ; Inc. Nov-27-2013 Synthes Titanium Cannulated Humeral Nail – Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Synthes USA HQ; Inc. Nov-27-2013 Synthes 4.5 mm LCP Curved Condylar Plate – Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures. The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

Synthes USA HQ; Inc. Nov-27-2013 Synthes Vertebropasty Needle Kit 10g Diamond Tip – Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.

Siemens Medical Solutions USA; Inc Nov-27-2013 Siemens RAD Flouro Uro – Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/GImage intensified Fluoroscopic X-ray system When using systems operating with software versions VD10A/G during a RAD examination; a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality; prompting repetition of the examination.

Ebi; Llc Nov-27-2013 Biomet The Polaris Spinal System; Shortened Plug Driver – Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine; Parsippany; NJ 07054The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system; a posterior hook and sacral/iliac screw fixation system; or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies); spondylolisthesis; and or lordosis) tumor; stenosis; pseudoarthrosis; or failed previous fusion Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT KEEL PUNCH CEMENTEDSIZE 1-1.5HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT PUNCH NONCEMENTEDSize 4-7HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT KEEL PUNCH CEMENTEDSize 2-3HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT KEEL PUNCH CEMENTEDSize 4-7HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT KEEL PUNCH NONCEMENTEDSize 1-1.5HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT KEEL PUNCH NONCEMENTEDSize 2-3HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT KEEL PUNCH NONCEMENTEDSize 4-7HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT PUNCH CEMENTEDSize 1-1.5HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT PUNCH CEMENTEDSize 2-3HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT PUNCH CEMENTEDSize 4-7HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT PUNCH NONCEMENTEDSize 1-1.5HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

DePuy Orthopaedics; Inc. Nov-27-2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" – SIGMA¿ LCS¿ HIGH PERFORMANCE"MBT PUNCH NONCEMENTEDSize 2-3HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. DePuy Orthopaedics; Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.

Synthes USA HQ; Inc. Nov-27-2013 Synthes Implant Holder for Synfix (TM)-LR – Synthes Implant Holder for Synfix (TM)-LRthe Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue; or for use with other devices in orthopedic surgery Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

Synthes USA HQ; Inc. Nov-29-2013 Synthes Soft Tissue Retractor Small Extendible – Synthes Soft Tissue Retractor Small Extendible.Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance