Browse Device Recalls

48 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 48 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 48 FDA device recalls.

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DateProductReasonClassFirm
Nov 21, 2024 OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Ser... Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential o... Class II GE OEC Medical Systems, Inc
Nov 21, 2024 OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC... Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential o... Class II GE OEC Medical Systems, Inc
Nov 21, 2024 OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OE... Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential o... Class II GE OEC Medical Systems, Inc
Nov 21, 2024 OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3... Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential o... Class II GE OEC Medical Systems, Inc
May 15, 2023 OEC Elite Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 OEC 9800 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 OEC 9900 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PAR... Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
May 15, 2023 OEC Flexiview 8800 Systems with 9-inch Image Intensifier Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... Class II GE OEC Medical Systems, Inc
Jun 10, 2021 OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and ... There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplet... Class II GE OEC Medical Systems, Inc
Jun 10, 2021 OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product... There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplet... Class II GE OEC Medical Systems, Inc
Feb 21, 2017 OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging f... Class II GE OEC Medical Systems, Inc
Dec 27, 2016 OEC 9800. MDL Numbers: D222250, D141598 GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ... Class II GE OEC Medical Systems, Inc
Dec 27, 2016 OEC 9900 Elite. MDL Numbers: D148942, D155043 GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ... Class II GE OEC Medical Systems, Inc
Dec 19, 2016 The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluorosco... GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... Class II GE OEC Medical Systems, Inc
Dec 19, 2016 OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile ... GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... Class II GE OEC Medical Systems, Inc
Dec 19, 2016 OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide ... GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit... Class II GE OEC Medical Systems, Inc
Sep 23, 2016 OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Produc... GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 6... Class II GE OEC Medical Systems, Inc
Jul 22, 2016 OEC 9800, fluoroscopic x-ray system A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monito... Class II GE OEC Medical Systems, Inc
Jul 22, 2016 OEC UroView 2800, fluoroscopic x-ray system A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monito... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to prov... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic an... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic a... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Oct 3, 2014 FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital M... GE Healthcare initiated a field correction because prior revision of components were potentially ... Class II GE OEC Medical Systems, Inc
Sep 15, 2014 GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgica... mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation o... Class II GE OEC Medical Systems, Inc
Sep 15, 2014 GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical... mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation o... Class II GE OEC Medical Systems, Inc
May 22, 2014 GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part numbe... Laser aimer assemblies were shipped without certification of the overall assembly or submitting a... Class II GE OEC Medical Systems, Inc
Mar 31, 2014 The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic ... GE Healthcare has identified a potential safety issue related to the screws that attach the works... Class II GE OEC Medical Systems, Inc
Nov 26, 2013 InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assis... GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENT... Class II GE OEC Medical Systems, Inc
Apr 26, 2010 GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB wi... GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not co... Class II GE OEC Medical Systems, Inc
Nov 6, 2009 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed ... GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer com... Class II GE OEC Medical Systems, Inc
Jun 22, 2009 OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); I... GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated... Class I GE OEC Medical Systems, Inc
Oct 10, 2008 GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certa... GE initiated a correction to the instructions/use due to the potential for erroneous auto injecti... Class II GE OEC Medical Systems, Inc
Feb 22, 2008 OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-ar... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
Nov 19, 2007 OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of ... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class II GE OEC Medical Systems, Inc
Nov 19, 2007 OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV ... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class II GE OEC Medical Systems, Inc
Nov 19, 2007 OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-ar... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class II GE OEC Medical Systems, Inc
Oct 19, 2007 GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt ... X-ray units did not meet manufacturer's specification for linearity. Class II GE OEC Medical Systems, Inc
Apr 2, 2007 Radiological Image Processing System The system is an aid to locate anatom... The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrec... Class I GE OEC Medical Systems, Inc
Mar 27, 2007 OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to ... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class II GE OEC Medical Systems, Inc
Mar 27, 2007 UroView 2800; MDL number A349855. Product Usage: Designed to provide fluor... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class II GE OEC Medical Systems, Inc
Mar 27, 2007 OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 680... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class II GE OEC Medical Systems, Inc
Nov 20, 2006 OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during di... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
Nov 20, 2006 OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system ... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
Nov 20, 2006 OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic... Recalled in November 2006 due to several intermittent potential safety issues including navigatio... Class II GE OEC Medical Systems, Inc
Nov 8, 2006 The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is... GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insert... Class II GE OEC Medical Systems, Inc
Oct 11, 2006 OEC InstaTrak 3500, picture archiving and communications system intended as a... GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to ... Class II GE OEC Medical Systems, Inc
Sep 15, 2006 InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, 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.