Philips Medical Systems Nederland B.v.: Philips Azurion 7 B20. Model Numbers: 722068, 722226
Recall Summary Philips is recalling Azurion 7 B20 X-ray systems (models 722068 and 722226) worldwide because they may contain hard drives not approved for medical use, which could fail and cause the system to lose imaging functionality, display a blank screen, or be unable to store or access images. This is a Class II recall affecting devices distributed across the US and numerous countries. The recall impacts healthcare facilities using these specific medical imaging systems.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 7 B20. Model Numbers: 722068, 722226.
- 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
- U.S. Food and Drug Administration
- Recall date
- 2026-10-06
- Status
- Ongoing
- 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 U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/56f9fd64-ec8c-462d-8931-92761f9e1cd3