Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion...

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15... on 2025-12-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.