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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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DateProductReasonClassFirm
Oct 8, 2015 Merge OrthoCase software. The firm name on the label is Merge Healthcare, H... Measurements in the software are changing after saving a plan with a measurement result, which ma... Class II Merge Healthcare, Inc.
Oct 1, 2015 Merge Cardio software. Merge Cardio is a system intended to be used to ac... Reporting feature times out after inactivity for more than an hour sending the user back to the s... Class II Merge Healthcare, Inc.
Sep 28, 2015 The Centricity PACS-IW with Universal Viewer is a device that displays medica... Inaccurate distance measurements with magnified projection X-ray images. Class II GE Healthcare
Sep 28, 2015 The Centricity Universal Viewer Version is a device that displays medical ima... Inaccurate distance measurements with magnified projection X-ray images. Class II GE Healthcare
Sep 22, 2015 Merge Cardio software. Product Usage: Merge Cardio is a system intended... Users can merge a device import file with an image study that already has a confirmed report, whi... Class II Merge Healthcare, Inc.
Sep 22, 2015 Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the... For sites using the Issuer of Patient ID (IPID), the system will display the study list and image... Class II Merge Healthcare, Inc.
Sep 16, 2015 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device tha... Images may be missing when a system parameter MapRoute is set to a value greater than 1. Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for di... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR syst... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family ... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging ... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 31, 2015 GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 ... When performing head or neck scans, the currently displayed SAR values could be lower than the ac... Class II GE Healthcare
Aug 11, 2015 Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PA... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Aug 11, 2015 Centricity Universal Viewer Product Usage: The Centricity Universal Viewe... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Jul 23, 2015 Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a... The software is unable to accurately determine the calcium score of scans with a slice thickness ... Class II Merge Healthcare, Inc.
Jul 17, 2015 PET Discovery ST 16 Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... Class II GE Healthcare
Jul 17, 2015 PET Discovery LS Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... Class II GE Healthcare
Jul 17, 2015 Lightspeed 16 CT Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... Class II GE Healthcare
Jul 10, 2015 GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; Ec... A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradien... Class II GE Healthcare
Jun 12, 2015 GE Healthcare, Precision MPi fluoroscopic imaging systems. A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision RXi Digital system A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision RXi 23A/32A Analog System A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Flu... The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This m... Class II GE Healthcare
Jun 12, 2015 GE Healthcare Precision 500D Classical R & F system. A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
May 31, 2015 The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2... Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to f... Class II Merge Healthcare, Inc.
May 29, 2015 GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiograph... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in genera... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 4, 2015 GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). The heart rate could be calculated from pacer pulses without indication that pacemaker detection ... Class II GE Healthcare
Apr 24, 2015 D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with... A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fe... Class II GE Healthcare
Apr 22, 2015 CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designe... GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of th... Class II GE Healthcare
Apr 9, 2015 Merge RadSuite software. Radiological image processing system. When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ... Class II Merge Healthcare, Inc.
Mar 30, 2015 Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-000... The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is ... Class II Merge Healthcare, Inc.
Mar 12, 2015 GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate ... GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of... Class II GE Healthcare
Mar 9, 2015 GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INF... GE Healthcare has become aware of a potential safety issue involving MRI systems due to software ... Class II GE Healthcare
Mar 9, 2015 Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, ... GE Healthcare has recently become aware of an improper installation of a ceiling suspended penden... Class II GE Healthcare
Mar 5, 2015 GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine system... GE Healthcare has recently become aware of a potential safety issue due to a collimator falling o... Class II GE Healthcare
Mar 5, 2015 Merge LIS software. There is a potential for duplicate container numbers to be created for patients. 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.