Philips Medical Systems Nederland B.v.: Philips Azurion 5 M20. Model Numbers: 722228, 722281
Recall Summary Philips is recalling Azurion 5 M20 imaging systems (model numbers 722228 and 722281) worldwide because some units may contain storage drives not approved for the device, which could cause imaging functionality problems, display failures, or loss of stored images over time. The recall affects systems distributed across the U.S. and numerous countries internationally. This is a Class II recall.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 5 M20. Model Numbers: 722228, 722281.
- 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/a8507cc2-8a25-4840-88ce-abc70037820c