Medical devices, 2012: every recall, from FDA

Medical device recall AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge… Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical Image Storage Devices - Media… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named

Medical device recall Hitachi Echelon MRI System/Oasis MRI, Software Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named

Medical device recall UniCel DxI 800 Access Immunoassay Systems The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall UniCel DxI 600 Access Immunoassay Systems The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Visual-ICE¿ Cryoablation System Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named

Medical device recall GEHC OEC Injection Cable for MedRad Provis V Contrast Injector GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700 Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one… FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall Neptune 1 Gold Rover Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one… FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For… Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one… FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or… Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one… FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer… FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use. The Beauty Angel was marketed without a 510k. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report… Content entered into the “Conclusions” free text box on the Report Writer screen was not represented on the final printed report. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Alaris Pump Module The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC Product is missing the label on the internal packaging. Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement Report26 statesnamed in where it went PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, Wisconsin and West Virginia

Medical device recall The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable… Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained… Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Illinois, Indiana, Maine and New Jersey named

Medical device recall Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub… Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall SenTec, V-Sign”2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive… SenTec is recalling a number of V-Sign”2 Sensors due to a problem regarding configuration parameter writing during manufacturing. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide, and Missouri named

Medical device recall 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized… BrainPath sheaths were mislabeled. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereMichigan

Medical device recall 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized… BrainPath sheaths were mislabeled. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereMichigan

Medical device recall Carestream DRX-1 System Battery Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version… GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Synthes(R) Hemostatic Bone Putty There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. FDA Class I, its most serious class Class IFDA’s classAug 22, 2012in FDA’s Enforcement Report27 statesnamed in where it went PublishedAug 22, 2012ClassClass IStatusTerminatedWhereAlaska, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin

Medical device recall Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Essenta DR C-Arm may fall Class IIFDA’s classAug 22, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereCalifornia, North Carolina and Tennessee

Medical device recall Philips Easy Diagnost Classic-Stationary x-ray system Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol… Class IIFDA’s classAug 22, 2012in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereIndiana, Massachusetts, Michigan, Missouri, North Carolina, New York, Pennsylvania, South Carolina and Wisconsin

Medical device recall COBAS AmpliPrep Sample Tube Input Barcode Clips Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode… Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt… Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the “hardened” cannula tip. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereMichigan and Minnesota

Medical device recall VITROS Chemistry Products DGXN Slides --- [REF] 834 3386 Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen… Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00… Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique… Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique… Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique… Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Sunquest Laboratory SMART & Sunquest Laboratory SMART Select In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the… In connection with a Warning Letter received from the U.S. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6… During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns” System 8000 bases were manufactured and distributed from… Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereNationwide, and New York named

Medical device recall Radiological Image Processing System The system is an aid to locate anatomical structures during open or… The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed… FDA Class I, its most serious class Class IFDA’s classAug 15, 2012in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 15, 2012ClassClass IStatusTerminatedWhereFlorida, Illinois, Indiana, Louisiana, Missouri, New Hampshire, New Jersey, Pennsylvania and Texas

Medical device recall SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in… Some clip applier units may be inadequate to achieve clip closure. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical devices, 2012

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