BEUDAMED
    FDA Recall Open, Classified

    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    Recall: Z-1819-2025 · Initiated March 21, 2025

    Recall

    Recall Number
    Z-1819-2025
    Event Number
    96902
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    OXO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 21, 2025
    Posted
    June 9, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    Reason

    OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

    Action

    All impacted customers with receive a customer letter notifying them of the potential issue. GE HealthCare will send a field service engineer to perform measurements of the Xray field on the identified systems (listed in Appendix A of the customer letter).

    Distribution

    US and OUS

    Quantity

    Total for both products: 3472 (2,919 US; 553 OUS)