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Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 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 33 FDA device recalls.

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DateProductReasonClassFirm
Jul 22, 2020 CombiDiagnost R90 Software Version R1.0 and R1.1 Philips has become aware of a software issue, where the kV and mA values are not locked immediate... Class II Philips Medical Systems Gmbh, DMC
Dec 19, 2019 CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... Class II Philips Medical Systems Gmbh, DMC
Dec 19, 2019 CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xr... When using the Table Up/Down button, the system may experience Error 80, which locks the geometry... Class II Philips Medical Systems Gmbh, DMC
Nov 7, 2018 Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stati... kV/mA lockin not functioning as specified which may result in the patient receiving an increased ... Class II Philips Medical Systems Gmbh, DMC
Sep 19, 2018 Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System ... Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts af... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 CombiDiagnost R90 (Stitching Patient Support) 709030 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 (Stitching Patient Support) 712225 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Upgrades (Stitching Patient Support) 712083 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Release 3 (Stitching Patient Support) 712025 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Release 3 (Stitching Patient Support) 712025 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Single Detector (Stitching Patient Support) 712020 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC
Jun 27, 2018 BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... Class II Philips Medical Systems Gmbh, DMC

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.