Medical devices, 2013: every recall, from FDA

Medical device recall Carestream Vue PACS Carestream Health, Inc. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Utah, Virginia, Washington and Wisconsin

Medical device recall Philips brand IntelliSpace PACS 4.4, Image Management System 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… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW… GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall Siemens syngo.plaza image processing system image processing radiological system The firm became aware of an unintended behavior when using the syngo.plaza. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Massachusetts, Minnesota, Missouri, North Carolina, New York, Ohio, Washington and Wisconsin named

Medical device recall Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL Label indicates, “Sweetened with xylitol and Sorbitol”, however product does not contain sorbitol. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Osseocare Pro Console & Set Osseocare Pro 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… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall S-LIFT Extension Shims Extension shims are Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Florida, Illinois, Kansas, Missouri, Ohio, Oklahoma, Oregon, Texas and Virginia named

Medical device recall DeRoyal (R) Surgical Eye Spears One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating 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… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportMichiganthe one state its words name PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereMichigan

Medical device recall VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral… 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… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Medtronic RestoreUltra Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Medtronic Activa PC Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Acetabular Pressurizer On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, North Dakota, New Jersey, Texas, Virginia and Wisconsin named

Medical device recall Ray Station Radiation Therapy Treatment Planning System Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee and Virginia

Medical device recall Draeger Movita 603x/DVE 803x Ceiling Supply Unit 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… Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two… Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and… Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and… Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and… Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and… Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and… Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Access 2 Immunoassay System Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage. Class IIFDA’s classNov 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named

Medical device recall Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F,… Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Baylis Medical TorFlex Transseptal Guiding Sheath 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… FDA Class I, its most serious class Class IFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 13, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Florida, Michigan, North Carolina, Nebraska, New Hampshire, Pennsylvania, Tennessee and Virginia named

Medical device recall Dekompressor Percutaneous Discectomy Probe 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… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Mississippi, North Dakota and Nebraska named

Medical device recall Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from… Class IIIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this… Zimmer recently conducted a review of historic packaging validations completed. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY Swapped product. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Iowa, Maryland, North Carolina, Ohio, Pennsylvania and Tennessee named

Medical device recall GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY Swapped product. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Iowa, Maryland, North Carolina, Ohio, Pennsylvania and Tennessee named

Medical device recall DRX Revolution Carestream Health Inc. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named

Medical device recall The EkoSonic Endovascular System employs high frequency The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610) 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… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Surgicutt fully automated incision making device for bleeding time determination ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona named

Medical device recall Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class… Potential for clinical errors. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Missouri, North Carolina, New Jersey, New Mexico, Oregon, Tennessee and West Virginia named

Medical device recall Patient Cart used in conjunction with the da Vinci S surgical and SI System Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 13, 2013ClassClass IIStatusTerminatedWherePuerto Rico

Medical device recall Harmony Equipment Management System 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… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin named

Medical device recall S5 Heart-lung machine, Stockert S5 System Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement Report14 statesnamed in where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Massachusetts, Maryland, North Dakota, New York, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin

Medical device recall Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices… The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall MLS Torpedo Mini-Light Ophthalmic single-port illumination 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… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Indiana, Massachusetts, Maryland, Texas and Washington named

Medical devices, 2013

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