Philips Medical Systems Nederland B.v.: Philips Azurion 3 M12. Model Numbers: 722063, 722221

Recall Summary Philips is recalling Azurion 3 M12 imaging systems (model numbers 722063 and 722221) worldwide because some units may contain hard drives that weren't approved for use in these devices. These unapproved drives could cause the system to malfunction, resulting in loss of imaging capabilities, display problems, or inability to save or access images.

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Philips Azurion 3 M12. Model Numbers: 722063, 722221.

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/7d037ec7-cd6e-4490-9347-1dd68d7d4844