Medical devices, 2013: every recall, from FDA

Medical device recall Churchill Medical Systems, Inc Product was packaged with the incorrect introducer needle. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 20, 2013ClassClass IIStatusTerminatedWherePennsylvania

Medical device recall Synthes Spine 5.2mm Titanium Click ’ X Pedicle Screw Dual Core 40 mm Thread Length Lot number 7542279, of the 45 mm Click ‘X Pedicle Screw (Part number 487.072), was incorrectly etched as “Click ‘X Pedicle Screw 05.2 L40 TAN violet” although… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Missouri, Mississippi, New Jersey, Oregon and Tennessee

Medical device recall Draeger Infinity Acute Care System (IACS) Monitoring Solution The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereCalifornia, Illinois and Massachusetts

Medical device recall GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of… FDA Class I, its most serious class Class IFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMar 20, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and West Virginia named

Medical device recall Large Combination Clamp/Large External Fixation System The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Florida, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named

Medical device recall Synthes Titanium Midface Distractor, MR Conditional There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereCalifornia, Louisiana, Massachusetts, New York and Pennsylvania

Medical device recall INTERNAL HEX RECON SCREW, TI-6AL-4V 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Kentucky, Massachusetts, Michigan, North Carolina, New Jersey, New Mexico, Ohio, Tennessee and Texas

Medical device recall Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedMar 20, 2013ClassClass 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, West Virginia and Wyoming named

Medical device recall Nicolet EEG Wireless Amplifier 32/64 Channel Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Louisiana, Maryland, Missouri, Mississippi, New Jersey, New York, Pennsylvania and Texas named

Medical device recall GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ… A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B Sporadic hang-up malfunctions concerning 3D reconstructions during activated “Preview Image” functionality. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall TotalCare SpO2RT2 bed In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to… Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole… This field change order is being released to update software and customer release notes to the affected installed base. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement Report19 statesnamed in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereArkansas, Arizona, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Mississippi, Montana, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Vermont, West Virginia and Wyoming

Medical device recall Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica… Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result. Class IIFDA’s classMar 20, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 20, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces… FDA Class I, its most serious class Class IFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMar 13, 2013ClassClass IStatusTerminatedWhereNationwide, and California, Georgia, Iowa, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, New Hampshire, New York, Pennsylvania, Rhode Island, Texas, Utah and Wisconsin named

Medical device recall Philips Digital Diagnost Stationary radiographic system When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then… Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation… Incorrect views and measurements possible. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas and Virginia

Medical device recall Century Console Base Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and Wisconsin

Medical device recall Synthes Multi-Vector Distractor Body It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Louisiana, Maryland, Minnesota, New York, Pennsylvania, Rhode Island, Tennessee, Texas and Utah named

Medical device recall Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right) It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Louisiana, Maryland, Minnesota, New York, Pennsylvania, Rhode Island, Tennessee, Texas and Utah named

Medical device recall Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left) It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Louisiana, Maryland, Minnesota, New York, Pennsylvania, Rhode Island, Tennessee, Texas and Utah named

Medical device recall Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System Incorrect values may be displayed. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement Report39 statesnamed in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Siemens became aware of a potential safety issue when using the “In-session resumption” feature of the syngo RT Therapist (RTT) 4.3 software. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous… Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with… Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous… Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with… Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Vacutainer PST Gel and Lithium Heparin (LH) BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube… Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall Atricure Inc., Max1 Isolator Transpolar Pen Products from lot no. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Maryland, Pennsylvania and Texas named

Medical device recall Beckman Coulter AU5800 Clinical Chemistry Analyzer Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample… Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of… The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Missouri, Nebraska, New Hampshire, New York, Ohio, Pennsylvania and Virginia named

Medical device recall AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used… The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated… Class IIFDA’s classMar 13, 2013in FDA’s Enforcement Report45 statesnamed in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered… The Membrane Switch Panel (referred to as “front panel” of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System,… Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Missouri, Nebraska, New York and Texas named

Medical device recall D3000I Advantage Drive System, 230v, surgical instrument motor The Membrane Switch Panel (referred to as “front panel” of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System,… Class IIIFDA’s classMar 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 13, 2013ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Missouri, Nebraska, New York and Texas named

Medical device recall PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC Damage to the packaging may have compromised the sterility of the device. Class IIFDA’s classMar 13, 2013in FDA’s Enforcement Report49 statesnamed in where it went PublishedMar 13, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall GE Healthcare Definium 5000 / 5220493 X-Ray System When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare Definium 5000/5220493-2 X-Ray System When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Michigan, Missouri, New Mexico and Wyoming named

Medical device recall Mx8000 IDT Whole Body Computed Tomography X-ray system The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming named

Medical device recall KY SENSITIVE TM JELLY Personal Lubricant This product is not cleared for marketing in the US. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall KY SilkE Vaginal Moisturizer and Personal Lubricant This product is not cleared for marketing in the US. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall KY TINGLING JELLY Personal Lubricant This product is not cleared for marketing in the US. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Avex CX Suite, Avex CX 0.22 UL4,5 HK Orthodontic brackets distributed was incorrectly labeled. Class IIIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 6, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado and Washington named

Medical device recall QuietCare-Networked product, Facility Server/model: QC101601 Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Versafitcup Impacting Ring Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Idaho, New York, Texas, Utah, Washington and Wisconsin named

Medical device recall BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Software anomaly. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners Software anomaly. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical devices, 2013

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