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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Mar 24, 2016 NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body comput... The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version... Class II Philips and Neusoft Medical Systems Co., Ltd.
Mar 4, 2013 NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This... User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report wher... Class II Philips And Neusoft Medical Systems Co., Ltd.
Mar 4, 2013 NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Mode... User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report wher... Class II Philips And Neusoft Medical Systems Co., Ltd.
Oct 18, 2012 NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz D... The four screws that secure the patient table top to the carrier pulled out and caused the table ... Class II Philips And Neusoft Medical Systems Co., Ltd.
Jun 8, 2012 NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system... One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz... Class II Philips And Neusoft Medical Systems Co., Ltd.

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.