Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 19081–19100 of 38,428 recalls

December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia 1.5T S

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: MARLIN 1.5T

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: MR-OR 3.0T

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: NZM101 Ingenia 1.5T Linac

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 3.0T X

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.5T Power/Pulsar

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.5T CV

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia 3.0T CX

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia 1.5T CX

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Multiva 1.5T

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Multiva 1.5T 16 R5

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.0T Omni/Stellar

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 1.5T High Performance

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 3.0T Master/Quasar Dual

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Prodiva CS

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia 1.5T

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 3.0T TX for PET

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Panorama 1.0T

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.5T Master/Nova

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera Achieva 1.5T IT Nova Dual

The Issue: There is a potential for the ceiling speaker(s)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated