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Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 922 FDA device recalls in WI.

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DateProductReasonClassFirm
Nov 7, 2013 GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph... There exists a software issue associated with patient selection from the worklist on the Optima X... Class II GE Healthcare, LLC
Oct 25, 2013 GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo ... GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan proce... Class II GE Healthcare, LLC
Oct 11, 2013 HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40,... GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings as... Class II GE Healthcare, LLC
Oct 11, 2013 GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... GE became aware of a potential safety issue due to a system slow down and system lock up associat... Class II GE Healthcare, LLC
Oct 9, 2013 GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Inten... There is an issue with the Manual Film Composer feature on some CT products. There is an opportu... Class II GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC
Sep 19, 2013 AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH... GE Healthcare has recently become aware of a potential safety issue due to the image orientation ... Class II GE Healthcare, LLC
Sep 19, 2013 Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos... GE Healthcare has recently become aware of a potential safety issue due to air leakage associated... Class I GE Healthcare, LLC
Sep 16, 2013 GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ... GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ... Class I GE Healthcare, LLC
Aug 30, 2013 GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is inte... GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device... Class II GE Healthcare, LLC
Aug 28, 2013 GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte... GE Healthcare has recently become aware of a potential safety issue involving unresponsive button... Class I GE Healthcare, LLC
Aug 16, 2013 GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100I... GE Healthcare has become aware of a potential safety issue involving missing screws in the overhe... Class II GE Healthcare, LLC
Aug 13, 2013 GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 ... GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on... Class II GE Healthcare, LLC
Aug 7, 2013 GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be u... GE has recently become aware of a potential safety issue due to the incorrect calculation of the ... Class II GE Healthcare, LLC
Aug 7, 2013 Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syrin... Manufacturer made a change in the production process that resulted in a change in final gel weigh... Class I Enhancement Medical, LLC
Jul 29, 2013 Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The D... GE Healthcare has recently become aware of a potential safety issue involving the pre-operative c... Class II GE Healthcare, LLC
Jun 19, 2013 GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The a... GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS... Class II GE Healthcare, LLC
Jun 13, 2013 Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Cam... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intend... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is inten... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
May 17, 2013 Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Te... RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Managemen... Class II RF Technologies, Inc.
May 14, 2013 Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or ... GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 ab... Class II GE Healthcare, LLC
May 9, 2013 GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... GE Healthcare has recently become aware of a potential safety issue with respect to the automated... Class II GE Healthcare, LLC
May 6, 2013 RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... Multiple studies were missing at a customer location that never made it to the archive before wat... Class II Merge Healthcare, Inc.
May 2, 2013 GE Healthcare, Precision 500D Product Usage: The Precision 500D is design... GE Healthcare has recently become aware of a potential safety issue involving the overhead Video ... Class II GE Healthcare, LLC
Apr 10, 2013 The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybr... GE Healthcare has recently become aware of an incident where the wrong part of the patient body w... Class II GE Healthcare, LLC
Apr 9, 2013 GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the fol... GE Healthcare has recently become aware of a potential safety issue due to non-unique series iden... Class II GE Healthcare, LLC
Apr 3, 2013 GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage... GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... Class II GE Healthcare, LLC
Apr 3, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Health... GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... Class II GE Healthcare, LLC
Apr 3, 2013 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The int... GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... Class II GE Healthcare, LLC
Mar 28, 2013 Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic res... Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. Class II GE Healthcare, LLC
Mar 28, 2013 MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic ... Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. Class II GE Healthcare, LLC
Mar 26, 2013 GE PET Discovery 610, PET Discovery 710. Intended for head and whole body ... GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio... Class II GE Healthcare, LLC
Mar 26, 2013 GE, Optima CT660. Intended to produce cross-sectional images of the body b... GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio... Class II GE Healthcare, LLC
Feb 27, 2013 Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-0154... Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat a... Class II Natus Neurology Incorporated
Feb 8, 2013 GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ ... GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe us... Class II GE Healthcare, LLC
Feb 4, 2013 Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanc... Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsist... Class II Genetic Testing Institute,inc
Jan 21, 2013 GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Inn... A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, I... Class II GE Healthcare, LLC
Jan 14, 2013 GE Healthcare Senographe Essential System. The Senographe 2000D system gen... GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instruc... Class II GE Healthcare, LLC
Jan 9, 2013 Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models... GE Healthcare has recently become aware of an incident which caused a patient injury during an un... Class II GE Healthcare, LLC
Jan 8, 2013 Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) label... Neonatal beds and incubator display boards may randomly overwrite stored information and radiant ... Class I GE Healthcare, LLC
Dec 18, 2012 Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For t... The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of... Class I Ad-Tech Medical Instrument Corporation
Nov 9, 2012 GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a ... GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data fr... Class II GE Healthcare, LLC
Nov 1, 2012 CADstream software. Product Usage: CADstream is an image processing syst... An incorrect biopsy or missed target could result if the incorrect grid is selected within the ap... Class II Merge Healthcare, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.