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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.