BEUDAMED
    FDA Recall Open, Classified

    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

    Recall: Z-0597-2026 · Initiated October 27, 2025

    Recall

    Recall Number
    Z-0597-2026
    Event Number
    98052
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    JAA
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 27, 2025
    Posted
    December 9, 2025
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

    Reason

    Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

    Action

    Philips will send a customer notification to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the SSD spacer to resolve the issue.

    Distribution

    U.S.

    Quantity

    110