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

Recall Z-2284-2023 — Azurion 7 M20. X-ray Image guided Therapy System.

U.S. FDA — Device Enforcement · Netherlands · 2023-06-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2284-2023
Date of alert
2023-06-12
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)
00884838085268
Reported risk: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
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.

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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.