PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Mod…

Recall date

December 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1079-2026

FDA classification

Class II

Brand / firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estoni…

Why it was recalled

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.