Medical devices, 2012: every recall, from FDA

Medical device recall V60 Ventilator, Continuous Ventilator Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. FDA Class I, its most serious class Class IFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured… Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia and West Virginia named

Medical device recall Orasure QuickFlu Rapid A+B Test There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Pennsylvania named

Medical device recall Poly stat Flu A & B Test There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Pennsylvania named

Medical device recall Status Flu A + B Test There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Pennsylvania named

Medical device recall Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to… Cook Ireland received a product complaint from Japan on December 22nd, 2011. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC… Exactech, Inc. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Illinois, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Tennessee, Texas, Virginia and Washington named

Medical device recall Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG… Cracks can arise on the welded seam on the rear joint. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereCalifornia, New York, Ohio, Oklahoma, Pennsylvania, Texas and Wyoming

Medical device recall Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear… Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using… Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra… Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and… Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall TxRx Knee 15 Coil 3T On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was… Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Tennessee named

Medical device recall Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the… Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Ohio and Texas named

Medical device recall BD GeneOhm MRSA ACP Assay Leakage in Cepheid SmartCycler reaction tubes. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall BD GeneOhm Cdiff Assay Leakage in Cepheid SmartCycler reaction tubes. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall BD GeneOhm VanR Assay Leakage in Cepheid SmartCycler reaction tubes. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was… Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas and Virginia named

Medical device recall Siemens Mobilett Mira During regular product monitoring, Siemens has become aware of a potential issue with the Mobilett Mira system. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Iowa, Idaho, Illinois, Kansas, North Carolina, Ohio, South Dakota, Texas and Wisconsin named

Medical device recall VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of… Class IIIFDA’s classSep 12, 2012in FDA’s Enforcement Report38 statesnamed in where it went PublishedSep 12, 2012ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Brand name: RayStation The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, New Jersey and New York named

Medical device recall 100 ft roll of tubing inside a cardboard box On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators. Class IIIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 12, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Indiana, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, South Dakota, Texas and Virginia named

Medical device recall Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation… This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. Class IIFDA’s classSep 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus);… GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500… FDA Class I, its most serious class Class IFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IStatusTerminatedWhereNationwide

Medical device recall ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange… FDA Class I, its most serious class Class IFDA’s classSep 5, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2012ClassClass IStatusTerminatedWhereNo state named

Medical device recall Cisco brand HealthPresence, version 2.1 Software anomaly may result in incorrect values and interpretations. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Tennessee named

Medical device recall syngo Imaging XS There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G… Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older… The systems all have a similar table control board. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number:… Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Mini-Infuser Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and… Class IIIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Low Profile Abutment, Non-Hexed Castable Cylinder Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Sunquest Laboratory LabAccess Results Workstation (LARS) The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall TRESTLE LUXE¿ Anterior Cervical Plating System On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Apelo Modular Screwdriver labeled in part: “APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine,… Atlas Spine, Inc. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereFlorida

Medical device recall syngo.plaza, Model number 10592457. Intended use: radiological image processing system. There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Washington and Wisconsin named

Medical device recall CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390… Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date,… Class IIIFDA’s classSep 5, 2012in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 5, 2012ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, Florida, Kansas, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Texas and Washington

Medical device recall EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504 The status display in the sequence queue window may not change from “Current” to “Done”. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall V Series Patient Monitors Mindray has identified two software anomalies contained in the V Series Monitoring System. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Puerto Rico, South Dakota, Texas, Washington and Wyoming named

Medical device recall Eon (Model 3716) IPG is a dual channel As of 11/30/2011, St. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system… As of 11/30/2011, St. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Whole Body X--ray Scanner This device is indicated as a whole body volume CT system 1. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Maryland, Montana, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania and Puerto Rico named

Medical device recall Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The… Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages… Class IIIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedSep 5, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid… STERIS has been actively seeking devices for quick connect revalidation projects. Class IIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, California, Colorado, Delaware, Florida, Illinois, Massachusetts, Maryland, North Carolina, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Wisconsin and West Virginia named

Medical device recall PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) Customers were not following the labeled assay procedure. Class IIIFDA’s classSep 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2012ClassClass IIIStatusTerminatedWhereNationwide

Medical devices, 2012

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