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

Recall Z-1176-2024 — Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280

U.S. FDA — Device Enforcement · Netherlands · 2024-02-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1176-2024
Date of alert
2024-02-06
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)
00884838099203
Reported risk: Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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