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

Recall Z-0835-2024 — Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 7220

U.S. FDA — Device Enforcement · Netherlands · 2023-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0835-2024
Date of alert
2023-12-12
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)
00884838085275
Reported risk: System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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