FDA Medical Device · Z-0294-2027

Philips Azurion 5 M12. Model Number: 722227.

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.

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Affected lots / codes — check yours against thisModel Number: 722227. UDI Numbers: (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)271, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)270, (01)00884838099227(21)246, (01)00884838099227(21)338, (01)00884838099227(21)108, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)104, (01)00884838099227(21)109, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)215, (01)00884838099227(21)213, (01)00884838099227(21)216, (01)00884838099227(21)226, (01)00884838099227(21)83, (01)00884838099227(21)251, (01)00884838099227(21)268, (01)00884838099227(21)309, (01)00884838099227(21)316, (01)00884838099227(21)290, (01)00884838099227(21)310, (01)00884838099227(21)345, (01)00884838099227(21)116, (01)00884838099227(21)153, (01)00884838099227(21)262, (01)00884838099227(21)204, (01)00884838099227(21)113, (01)00884838099227(21)110, (01)00884838099227(21)256, (01)00884838099227(21)308, (01)00884838099227(21)90, (01)00884838099227(21)200, (01)00884838099227(21)362, (01)00884838099227(21)242, (01)00884838099227(21)136, (01)00884838099227(21)95, (01)00884838099227(21)2, (01)00884838099227(21)221, (01)00884838099227(21)165, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)284, (01)00884838099227(21)248, (01)00884838099227(21)26, (01)00884838099227(21)292, (01)00884838099227(21)58, (01)00884838099227(21)130, (01)00884838099227(21)125, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)131. Serial Numbers: 135, 88, 271, 127, 128, 179, 270, 246, 338, 108, 305, 356, 346, 313, 104, 109, 337, 306, 215, 213, 216, 226, 83, 251, 268, 309, 316, 290, 310, 345, 116, 153, 262, 204, 113, 110, 256, 308, 90, 200, 362, 242, 136, 95, 2, 221, 165, 16, 12, 257, 284, 248, 26, 292, 58, 130, 125, 184, 57, 131.
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best,
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
60 units
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
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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-0294-2027%22
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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.
Check this brand across all 8 databases →