Philips Medical Systems Nederland B.v.: Philips Azurion 5 M12. Model Number: 722227
Recall Summary Philips is recalling the Azurion 5 M12 medical imaging device because some units may contain hard drives that don't meet specifications, potentially causing performance problems like loss of imaging capability, blank displays, or inability to save or access images. The device has been distributed worldwide, including throughout the United States. This is classified as a Class II recall, indicating a serious issue that could result in adverse health effects.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 5 M12. Model Number: 722227.
- 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/58e8240a-31a4-4b07-b4dd-bcad087bd683