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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Oct 22, 2018 NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-S... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
Oct 22, 2018 NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT ... Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) oc... Class II Neusoft Medical Systems Co., Ltd.
May 19, 2017 Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Mul... Software defect Class II Neusoft Medical Systems Co., Ltd.
May 19, 2017 Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: Neu... Software defect Class II Neusoft Medical Systems Co., Ltd.
Aug 31, 2016 NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P0... The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... Class II Neusoft Medical Systems Co., Ltd.
Aug 31, 2016 NeuViz 64 Multi-slice CT Scanner Systems The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... Class II Neusoft Medical Systems Co., Ltd.
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.
May 2, 2015 NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e,... It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1... Class II 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.