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

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M — recall Z-1152-2024

U.S. FDA — Device Enforcement · Netherlands · 2024-01-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1152-2024
Date of alert: 2024-01-02
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: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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