Philips Medical Systems Nederland B.v.: Interventional Fluoroscopic X-ray System
Recall Summary Philips is recalling certain Azurion 7 B12 X-ray systems (model numbers 722067 and 722225) because they may contain hard drives that don't meet specifications and could fail over time. Potential failures include loss of imaging capability, blank screens, or inability to save or access images. The affected devices were distributed worldwide, including throughout the United States.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 7 B12. Model Numbers: 722067, 722225.
- 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/02dd8950-7841-4c89-86be-dacf70aa9ca6