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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Jun 6, 2014 AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicate... When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize... Class II AGFA Corp.
Apr 30, 2014 IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optic... Failure to effectively install and test a hotfix to correct the known software defect within the ... Class II AGFA Corp.
Jan 8, 2014 IMPAX RIS QDOC 5.8 Patient name displayed (printed) on the Patient Report was the wrong patient name. Class II AGFA Corp.
Sep 19, 2013 IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Arch... System downtime and/or slow performance may result if software in use is an old version of IMPAX ... Class II AGFA Corp.
May 15, 2013 AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicate... Customers could potentially experience intermittent, unintended and illogical movement when using... Class II AGFA Corp.
Mar 15, 2013 IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Repor... Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheter... Class II AGFA Corp.
Mar 15, 2013 IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitat... Software design error in IMPAX CV 7.8 SU3 Class II AGFA Corp.
Feb 7, 2013 CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 4... The cassettes were shipped with the wrong IP (image plate) size bar code. Class II AGFA Corp.
Aug 9, 2012 AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMSt... Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore ... Class II AGFA Corp.
Jul 27, 2012 IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured rep... Content entered into the "Conclusions" free text box on the Report Writer screen was not represen... Class II AGFA Corp.
Jul 10, 2012 IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting componen... When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reportin... Class II AGFA Corp.

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.