Philips Medical Systems Nederland B.v.: Philips Azurion 7 B12. Model Numbers: 722067, 722225

Philips is recalling certain Azurion 7 B12 imaging systems (model numbers 722067 and 722225) distributed worldwide because some units may contain hard drives that weren't approved for use in these devices, which could cause performance problems like loss of imaging functionality, display issues, or inability to save or access images. This is a Class II recall affecting systems in the US and numerous countries internationally. The issue stems from unapproved solid-state drives potentially having reduced reliability over time.

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Philips Azurion 7 B12. Model Numbers: 722067, 722225.

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/8becd255-d4ff-410e-8cc5-619e21ce1ab6