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

Recall Z-1647-2023 — Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 72

U.S. FDA — Device Enforcement · Netherlands · 2023-03-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1647-2023
Date of alert: 2023-03-21
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: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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