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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Mar 23, 2024 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/7... Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not select... Class II Philips Ultrasound, Inc.
Oct 9, 2023 Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), E... Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... Class II Philips Ultrasound, Inc.
Oct 9, 2023 Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 Their is the potential that diagnostic ultrasound systems operating with software version 10.0 ma... Class II Philips Ultrasound, Inc.
Jun 30, 2023 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affin... Transducer, an ultrasound system accessory, consists of two parts that are bonded together that m... Class II Philips Ultrasound, Inc.
Aug 19, 2021 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100... Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... Class II Philips Ultrasound Inc
Aug 19, 2021 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100... Battery system data issue with the ultrasound system can intermittently cause a system shutdown, ... Class II Philips Ultrasound Inc
Mar 28, 2016 EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, ... The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound Syst... Class II Philips Ultrasound, Inc.
Dec 9, 2015 Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: ... Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow dire... Class II Philips Ultrasound, Inc.
May 15, 2015 Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catal... Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or hi... Class II Philips Ultrasound, Inc.
Apr 14, 2015 EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardi... When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and... Class II Philips Ultrasound, Inc.
Apr 14, 2015 EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardi... When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and... Class II Philips Ultrasound, Inc.
Apr 10, 2015 EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EP... When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weig... Class II Philips Ultrasound, Inc.
Apr 10, 2015 EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EP... When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weig... Class II Philips Ultrasound, Inc.
Nov 5, 2014 Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 5, 2014 EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 5, 2014 EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 5, 2014 Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Jul 9, 2014 QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a softw... The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... Class II Philips Ultrasound, Inc.
Jul 9, 2014 QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a sof... The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under spe... Class II Philips Ultrasound, 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.