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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Apr 19, 2019 IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be ... Images may potentially become corrupt while using the system. Class II Philips Healthcare Informatics, Inc.
Jul 24, 2014 Philips IntelliSpace PACS 4.4 image management systems performs digital image... A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information... Class II Philips Healthcare Informatics, Inc.
May 5, 2014 Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50... When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error ca... Class II Philips Healthcare Informatics, Inc.
Oct 14, 2013 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... Class II Philips Healthcare Informatics, 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.