Philips Medical Systems Nederland B.v.: Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282
Recall Summary Philips is recalling certain Azurion 7 M20 imaging systems (model numbers 722079, 722224, 722282) worldwide because some units may contain storage drives that don't meet specifications, potentially causing problems like loss of imaging capability, display issues, or inability to save or access images. This is a Class II recall affecting medical facilities that use these systems.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
- 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/29ca00da-6a55-4fcd-869f-5593914c978c