Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1079-2026 — 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

U.S. FDA — Device Enforcement · Netherlands · 2025-12-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1079-2026
Date of alert
2025-12-08
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838116726
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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