Official recall record
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-08
- Country of alert
- Netherlands
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00884838116726
- Brand on record
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-07-16 · US FDA — Medical Devices
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223 - 2026-07-16 · US FDA — Medical Devices
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Soft
All 73 official recall notices naming PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on this site →