Medical device recalls: April 2012
The FDA posted 122 medical device recall records in April 2012, from 73 recall events by 56 companies. 122 have not been classified yet.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Biomet, Inc. · 4 events, 4 records
- Abbott Laboratories Inc. · 3 events, 3 records
- Baxa Corporation · 3 events, 3 records
- Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
- Terumo Cardiovascular Systems Corporation · 2 events, 9 records
- Beckman Coulter Inc. · 2 events, 5 records
- Philips Medical Systems (Cleveland) Inc · 2 events, 5 records
- Roche Diagnostics Operations, Inc. · 2 events, 3 records
FDA root cause
- Nonconforming Material/Component · 45
- Device Design · 20
- Software design · 13
- Labeling design · 7
- Process control · 6
- Labeling mix-ups · 5
- Component design/selection · 5
- Software design (manufacturing process) · 4
Not yet classified (122)
The FDA has posted these records but has not published a class for them yet.
- Z-1477-2012 · Ogenix Corporation · posted Apr 30, 2012 · Terminated
Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date.
- Z-1478-2012 · Biomet, Inc. · posted Apr 30, 2012 · Terminated
The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation
- Z-1476-2012 · Stanley Security Solutions, Inc. · posted Apr 28, 2012 · Terminated
Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system
- Z-1473-2012 · Leica Microsystems, Inc. · posted Apr 27, 2012 · Terminated
There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. The end result may lead to damage or to loss of tissue specimens.
- Z-1474-2012 · Visicu, Inc. · posted Apr 27, 2012 · Terminated
Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
- Z-1475-2012 · Stanley Security Solutions, Inc. · posted Apr 27, 2012 · Terminated
Monitor gives false alarms
- Z-1463-2012 · Hospira Inc. · posted Apr 26, 2012 · Terminated
Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.
- Z-1464-2012 · Philips Healthcare Inc. · posted Apr 26, 2012 · Terminated
Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
- Z-1465-2012 · Medical Information Technology, Inc. · posted Apr 26, 2012 · Terminated
Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.
- Z-1466-2012 · Alere San Diego · posted Apr 26, 2012 · Terminated
Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased…
- Z-1467-2012 · Alere San Diego · posted Apr 26, 2012 · Terminated
Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased…
- Z-1468-2012 · Ortho-Clinical Diagnostics · posted Apr 26, 2012 · Terminated
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Z-1469-2012 · Ortho-Clinical Diagnostics · posted Apr 26, 2012 · Terminated
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Z-1470-2012 · Ortho-Clinical Diagnostics · posted Apr 26, 2012 · Terminated
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Z-1471-2012 · Ortho-Clinical Diagnostics · posted Apr 26, 2012 · Terminated
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Z-1472-2012 · Ortho-Clinical Diagnostics · posted Apr 26, 2012 · Terminated
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Z-1454-2012 · Siemens Healthcare Diagnostics, Inc. · posted Apr 25, 2012 · Terminated
Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective…
- Z-1455-2012 · Aesculap Implant Systems · posted Apr 25, 2012 · Terminated
The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.
- Z-1456-2012 · Biomet 3i, LLC · posted Apr 25, 2012 · Terminated
Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.
- Z-1457-2012 · Winco Mfg., LLC · posted Apr 25, 2012 · Terminated
Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the…
- Z-1458-2012 · Winco Mfg., LLC · posted Apr 25, 2012 · Terminated
Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the…
- Z-1459-2012 · Winco Mfg., LLC · posted Apr 25, 2012 · Terminated
Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the…
- Z-1460-2012 · Winco Mfg., LLC · posted Apr 25, 2012 · Terminated
Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the…
- Z-1461-2012 · Winco Mfg., LLC · posted Apr 25, 2012 · Terminated
Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the…
- Z-1462-2012 · Philips Healthcare Inc. · posted Apr 25, 2012 · Terminated
The monitor Ceiling suspension may fail, which may cause the monitor to drop.
- Z-1399-2012 · GE Healthcare, LLC · posted Apr 24, 2012 · Terminated
GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.
- Z-1448-2012 · Fresenius Medical Care Holdings, Inc. · posted Apr 24, 2012 · Terminated
Increased risk of intraperitoneal volume (IIPV), referred to as Overfill
- Z-1447-2012 · Abbott Laboratories Inc. · posted Apr 23, 2012 · Terminated
This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 U/L. In other cases the following errors may be…
- Z-1449-2012 · Biomet, Inc. · posted Apr 23, 2012 · Terminated
Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
- Z-1450-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 23, 2012 · Terminated
Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies…
- Z-1451-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 23, 2012 · Terminated
Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies…
- Z-1452-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 23, 2012 · Terminated
Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies…
- Z-1453-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 23, 2012 · Terminated
Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies…
- Z-1445-2012 · Boston Scientific CRM Corp · posted Apr 20, 2012 · Terminated
Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.
- Z-1446-2012 · Alere San Diego dba Biosite Innovacon Hemosense Inc · posted Apr 20, 2012 · Terminated
The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
- Z-1438-2012 · Biomet, Inc. · posted Apr 19, 2012 · Terminated
Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and measured against…
- Z-1439-2012 · Biomet, Inc. · posted Apr 19, 2012 · Terminated
Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.
- Z-1440-2012 · Synaptic Corp · posted Apr 19, 2012 · Terminated
Device was distributed without marketing approval.
- Z-1441-2012 · Advanced Bionics Corporation · posted Apr 19, 2012 · Terminated
The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
- Z-1442-2012 · Medtronic Sofamor Danek USA Inc · posted Apr 19, 2012 · Terminated
Drill stops may be bypassed when the device is used with powered drilling instruments.
- Z-1443-2012 · Medtronic Sofamor Danek USA Inc · posted Apr 19, 2012 · Terminated
Drill stops may be bypassed when the device is used with powered drilling instruments.
- Z-1444-2012 · Medtronic Sofamor Danek USA Inc · posted Apr 19, 2012 · Terminated
Drill stops may be bypassed when the device is used with powered drilling instruments.
- Z-1434-2012 · Abbott Laboratories Inc. · posted Apr 18, 2012 · Terminated
Observed particulate matter in some reagent cartridges.
- Z-1435-2012 · Howmedica Osteonics Corp dba Stryker Craniomaxillofacial · posted Apr 18, 2012 · Terminated
The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
- Z-1437-2012 · Teva Pharmaceuticals USA, Inc. · posted Apr 18, 2012 · Terminated
Lack of assurance of sterility
- Z-1421-2012 · Deroyal Industries, Inc. Lafollette · posted Apr 17, 2012 · Terminated
Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable.
- Z-1422-2012 · Deroyal Industries, Inc. Lafollette · posted Apr 17, 2012 · Terminated
Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable.
- Z-1423-2012 · Deroyal Industries, Inc. Lafollette · posted Apr 17, 2012 · Terminated
Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable.
- Z-1433-2012 · Siemens Healthcare Diagnostics, Inc. · posted Apr 17, 2012 · Terminated
Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium
- Z-1424-2012 · DePuy Orthopaedics, Inc. · posted Apr 16, 2012 · Terminated
DePuy Orthopaedics, Inc. is issuing a Recall Notice for nine lots of the Attune" Impaction Handle due to the potential for the handle trigger to break during surgery. The Attune Impactor is provided as a part of a set of tools and is designed specifically…
- Z-1425-2012 · Abbott Laboratories Inc. · posted Apr 16, 2012 · Terminated
Abbott Laboratories has issued a recall on the Clinical Chemistry Total Bilirubin due to an under-recovery on one clinical neonatal specimen resulting in a value less than the assay linear limit.
- Z-1426-2012 · DePuy Orthopaedics, Inc. · posted Apr 16, 2012 · Terminated
Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (inner pouch and outer pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility.
- Z-1427-2012 · Teleflex Medical · posted Apr 16, 2012 · Terminated
Teleflex Medical received complaints that the bite block can become separated from the handle. If separation occurs, medical intervention may be required to remove the bite block from the patient's trachea or esophagus/GI tract.
- Z-1428-2012 · Integra LifeSciences Corp. · posted Apr 16, 2012 · Terminated
The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.
- Z-1429-2012 · North Coast Medical Inc · posted Apr 16, 2012 · Terminated
Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs.
- Z-1430-2012 · Ziehm Imaging Inc · posted Apr 16, 2012 · Terminated
On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray as the foot…
- Z-1431-2012 · KCI USA, Inc. · posted Apr 16, 2012 · Terminated
The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
- Z-1432-2012 · Beckman Coulter Inc. · posted Apr 16, 2012 · Terminated
The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
- Z-1400-2012 · Scottcare Corporation · posted Apr 13, 2012 · Terminated
Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.
- Z-1401-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1402-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1403-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1404-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1405-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1406-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1407-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1408-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1409-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1410-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1411-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1412-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1413-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1414-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1415-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1416-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1417-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1418-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1419-2012 · MOOG Medical Devices Group · posted Apr 13, 2012 · Terminated
Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
- Z-1420-2012 · Baxa Corporation · posted Apr 13, 2012 · Terminated
Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
- DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 ↗Z-1396-2012 · DeRoyal Industries Inc · posted Apr 12, 2012 · Terminated
Device's needle may become dislodged from the cup during shipment or during use.
- Z-1397-2012 · DeRoyal Industries Inc · posted Apr 12, 2012 · Terminated
Device's needle may become dislodged from the cup during shipment or during use.
- Z-1398-2012 · DeRoyal Industries Inc · posted Apr 12, 2012 · Terminated
Device's needle may become dislodged from the cup during shipment or during use.
- Z-1387-2012 · Roche Diagnostics Operations, Inc. · posted Apr 11, 2012 · Terminated
An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum…
- Z-1388-2012 · Roche Diagnostics Operations, Inc. · posted Apr 11, 2012 · Terminated
An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum…
- Z-1393-2012 · Boston Scientific Corporation · posted Apr 11, 2012 · Terminated
Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in the 5-pack box may…
- Z-1394-2012 · Boston Scientific Corporation · posted Apr 11, 2012 · Terminated
Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in the 5-pack box may…
- Z-1395-2012 · Spectranetics Corp. · posted Apr 11, 2012 · Terminated
Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
- Z-1385-2012 · Varian Medical Systems, Inc. · posted Apr 10, 2012 · Terminated
Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.
- Z-1391-2012 · Siemens Healthcare Diagnostics, Inc. · posted Apr 10, 2012 · Terminated
QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.
- Z-1392-2012 · Biocare Medical Llc · posted Apr 10, 2012 · Terminated
Reports of sporadic failure of specific lots of Vina Green Chromogen Kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen.
- Z-1383-2012 · Siemens Medical Solutions USA, Inc · posted Apr 9, 2012 · Terminated
During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered that the wrench…
- Z-1384-2012 · Sendx Medical Inc · posted Apr 9, 2012 · Terminated
The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.
- Z-1386-2012 · Roche Diagnostics Operations, Inc. · posted Apr 9, 2012 · Terminated
Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through eBay by an unauthorized third party. These meters were…
- Z-1389-2012 · Baxa Corporation · posted Apr 9, 2012 · Terminated
Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
- Z-1390-2012 · Siemens Healthcare Diagnostics, Inc · posted Apr 9, 2012 · Terminated
Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
- Z-1372-2012 · Beckman Coulter Inc. · posted Apr 6, 2012 · Terminated
The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
- Z-1373-2012 · Beckman Coulter Inc. · posted Apr 6, 2012 · Terminated
The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
- Z-1374-2012 · Beckman Coulter Inc. · posted Apr 6, 2012 · Terminated
The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
- Z-1375-2012 · Beckman Coulter Inc. · posted Apr 6, 2012 · Terminated
The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
- Z-1376-2012 · Animas Corporation · posted Apr 6, 2012 · Terminated
There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the…
- Z-1377-2012 · Wako Chemicals USA, Inc. · posted Apr 6, 2012 · Terminated
In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
- Z-1378-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 6, 2012 · Terminated
Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
- Z-1379-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 6, 2012 · Terminated
Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
- Z-1380-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 6, 2012 · Terminated
Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
- Z-1381-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 6, 2012 · Terminated
Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
- Z-1382-2012 · Terumo Cardiovascular Systems Corporation · posted Apr 6, 2012 · Terminated
Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
- Z-1335-2012 · Milabs Bv · posted Apr 5, 2012 · Terminated
These products have doors which are not equipped with at least one safety interlock which physically disconnects power to the high voltage power supply for the x-ray source. Additionally, these products do not have a certification label and the…
- Z-1366-2012 · Philips Medical Systems (Cleveland) Inc · posted Apr 5, 2012 · Terminated
TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will…
- Z-1367-2012 · Philips Medical Systems (Cleveland) Inc · posted Apr 5, 2012 · Terminated
TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will…
- Z-1368-2012 · Philips Medical Systems (Cleveland) Inc · posted Apr 5, 2012 · Terminated
TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will…
- Z-1369-2012 · Philips Medical Systems (Cleveland) Inc · posted Apr 5, 2012 · Terminated
TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will…
- Z-1370-2012 · Hologic, Inc. · posted Apr 5, 2012 · Terminated
SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
- Z-1371-2012 · Baxa Corporation · posted Apr 5, 2012 · Terminated
Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.
- Z-1362-2012 · Maquet Inc. · posted Apr 3, 2012 · Terminated
The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
- Z-1363-2012 · Maquet Inc. · posted Apr 3, 2012 · Terminated
The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
- Z-1365-2012 · Computerized Medical Systems Inc · posted Apr 3, 2012 · Terminated
An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
- Z-1357-2012 · Acumed LLC · posted Apr 2, 2012 · Terminated
The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.
- Z-1358-2012 · Gendex Dental Systems · posted Apr 2, 2012 · Terminated
Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
- Z-1359-2012 · Lifescan Inc · posted Apr 2, 2012 · Terminated
An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display.
- Z-1360-2012 · Spinetronics, LLC · posted Apr 2, 2012 · Terminated
On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and represented a major change or modification in the intended use of the device.
- Z-1361-2012 · Philips Medical Systems (Cleveland) Inc · posted Apr 2, 2012 · Terminated
Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having Software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined…
- Z-1364-2012 · Siemens Medical Solutions USA, Inc · posted Apr 2, 2012 · Terminated
During product monitoring, Siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. The cable connections overheated, leading to the emission of smoke and possible material damage.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.