Philips Medical Systems Nederland B.v.: Interventional Fluoroscopic X-ray System
Recall Summary Philips is recalling certain Azurion 3 M12 X-ray systems because unauthorized solid-state drives may have been installed, which could cause problems like loss of imaging, blank displays, or inability to save or access images. The systems were distributed worldwide, including throughout the United States. This is a Class II recall, meaning the issue could cause serious health problems but is unlikely to cause death.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 3 M12. Model Numbers: 722063, 722221.
- Reason
- Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-10-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e08b301e-d1ce-4f1b-8d5e-ee9a9184c1a9