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

Recall Z-2534-2024 — Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neu

U.S. FDA — Device Enforcement · Netherlands · 2024-07-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2534-2024
Date of alert: 2024-07-15
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 Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

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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