Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

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Date	Product	Reason	Class	Firm
Sep 20, 2012	GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183...	GE Healthcare has recently become aware that patient mismatch without a warning message could occ...	Class II	GE Healthcare, LLC
Sep 20, 2012	GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of ...	It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p...	Class II	GE Healthcare, LLC
Sep 15, 2012	Centricity PACS System versions 3.X and higher and 4.X and higher Product Us...	There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam tra...	Class II	Ge Healthcare It
Aug 16, 2012	GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging syst...	GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 21...	Class II	GE Healthcare, LLC
Aug 13, 2012	GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use ...	GE Healthcare became aware of a potential issue related to incorrect image measurement associated...	Class II	GE Healthcare, LLC
Aug 7, 2012	GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The s...	GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx,...	Class II	GE Healthcare, LLC
Aug 3, 2012	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/ Mode...	Class II	GE Healthcare, LLC
Aug 1, 2012	GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic M...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Aug 1, 2012	GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mob...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Aug 1, 2012	GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic M...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Jul 20, 2012	CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is ...	GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. The...	Class II	GE Healthcare, LLC
Jul 13, 2012	GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. ...	GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an ...	Class II	GE Healthcare, LLC
Jul 12, 2012	GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul...	GE Healthcare has recently become aware of a number of potential issues associated with the CARE...	Class II	GE Healthcare, LLC
Jul 10, 2012	Optima XR200amx. Mobile general purpose radiographic imaging of the human he...	Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects...	Class II	GE Healthcare, LLC
Jul 10, 2012	Optima XR220amx Mobile general purpose radiographic imaging of the human h...	Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects...	Class II	GE Healthcare, LLC
Jul 2, 2012	Merge HEMO software.	The International Normalized Ratio (INR) value displayed in the study report does not match the v...	Class II	Merge Healthcare, Inc.
Jun 28, 2012	GE Healthcare, AW Server. Product Usage: . AW Server is a medical softwar...	GE Healthcare has recently become aware of a potential safety issue with respect to the Results V...	Class II	GE Healthcare, LLC
Jun 26, 2012	GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monito...	GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom ...	Class II	GE Healthcare, LLC
Jun 26, 2012	GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal...	Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In...	Class I	GE Healthcare, LLC
Jun 15, 2012	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha...	Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety ri...	Class II	Ge Healthcare It
Jun 13, 2012	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monit...	GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. The...	Class II	GE Healthcare, LLC
Jun 13, 2012	GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking st...	GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor....	Class II	GE Healthcare, LLC
Jun 12, 2012	GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 201...	GE Healthcare has become aware through complaints of a potential safety issue with its Invasive B...	Class II	GE Healthcare, LLC
Jun 8, 2012	GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without ...	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod...	Class II	GE Healthcare, LLC
Jun 8, 2012	GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnos...	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod...	Class II	GE Healthcare, LLC
Jun 8, 2012	GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR ...	GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Prod...	Class II	GE Healthcare, LLC
May 29, 2012	Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a...	GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis...	Class II	GE Healthcare, LLC
May 25, 2012	GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Vie...	Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safe...	Class II	GE Healthcare, LLC
May 24, 2012	GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advanta...	GE Healthcare has become aware of an issue associated with the magnification images acquired on n...	Class II	GE Healthcare, LLC
May 24, 2012	GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4....	GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol o...	Class II	GE Healthcare, LLC
May 24, 2012	AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 516009...	It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, t...	Class II	GE Healthcare, LLC
May 24, 2012	GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 an...	GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdv...	Class II	GE Healthcare, LLC
May 24, 2012	GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View...	GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT...	Class II	GE Healthcare, LLC
Apr 23, 2012	GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Produ...	GE Healthcare has recently become aware of a potential issue due to image flip in frequency encod...	Class II	GE Healthcare, LLC
Apr 19, 2012	The GE Centricity Web; Software Version 3.0x, is intended for use under the d...	GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco...	Class II	Ge Healthcare It
Apr 10, 2012	GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-O...	GE Healthcare has recently become aware of a potential safety issue due to the interlock slide me...	Class I	GE Healthcare, LLC
Apr 4, 2012	GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (A...	GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr...	Class II	GE Healthcare, LLC
Mar 27, 2012	GE Healthcare, Advantage Workstation, READY View Application. Image analys...	GE Healthcare has become aware that when analyzing fMRI images using the READY View application s...	Class II	GE Healthcare, LLC
Mar 6, 2012	GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Op...	Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomogra...	Class II	GE Healthcare, LLC
Feb 20, 2012	enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW D...	The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 109...	Class II	Vital Signs Devices, a GE Healthcare Company
Feb 17, 2012	GE Healthcare Carescape Patient Data Module with v2.0 software used with Sola...	GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software ...	Class II	GE Healthcare, LLC
Jan 23, 2012	VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139;...	GE Healthcare has become aware of an issue associated with the base casting for the articulated a...	Class II	GE Healthcare, LLC
Jan 4, 2012	GE Healthcare Muse v7 cardiology information system. Model number 2026443-00...	GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on ...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ,...	While performing a fluoroscopic examination on the GE Innova systems, there is a potential of non...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare innova 3100, Mobile X-ray system. The innova systems are in...	It was discovered of a potential failure of the spectral filter mechanism inside the collimator o...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are ...	It was discovered of a potential failure of the spectral filter mechanism inside the collimator o...	Class II	GE Healthcare, LLC
Dec 20, 2011	GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are i...	It was discovered of a potential failure of the spectral filter mechanism inside the collimator o...	Class II	GE Healthcare, LLC
Nov 21, 2011	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWIN...	Screen save images are included in wrong exam due to duplicate UID creation. This may cause a saf...	Class II	GE Healthcare, LLC
Oct 28, 2011	Fusion Workstation.; Indicated for the transmission and review of radiologica...	After a period of time running Fusion Workstation, the Hounsfield measurement tool will report in...	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.