BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0597-2026 · Reported December 17, 2025

    Enforcement

    Recall Number
    Z-0597-2026
    Event ID
    98052
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    December 17, 2025
    Initiation Date
    October 27, 2025
    Classification Date
    December 9, 2025
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    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.

    Code Info

    Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016

    Distribution

    U.S.

    Quantity

    110