Philips Medical Systems Nederland B.v.: Philips Azurion 3 M15. Model Number: 722064, 722222, 722280
Recall Summary Philips is recalling certain Azurion 3 M15 imaging systems (model numbers 722064, 722222, 722280) worldwide because some units may contain hard drives that weren't approved for use in these devices. These unapproved drives could fail over time, potentially causing imaging systems to stop working, displays to go blank, or the ability to save or view images to be lost.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
- 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/1126fbe7-715b-4b74-bedd-a9a01307ebaf