FDA Medical Device · Z-0300-2027

Philips Azurion S. Model Number: 722285.

Class II · Ongoing

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.

Affected lots / codes — check yours against this1. Model Number: 722285. UDI Number: (01)00884838125681(21)7. Serial Number: 7.

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best,
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 1 unit
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, Chile…
Recall initiated: October 6, 2026
Classified: October 27, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0300-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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