BEUDAMED
    FDA Recall Open, Classified

    Senographe Pristina

    Recall: Z-0862-2024 · Initiated December 26, 2023

    Recall

    Recall Number
    Z-0862-2024
    Event Number
    93837
    Firm
    GE Medical Systems, SCS
    FEI Number
    1000284313
    Product Code
    MUE
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 26, 2023
    Posted
    February 8, 2024
    Address
    283 rue de la Miniere Buc France

    Description

    Senographe Pristina

    Reason

    X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

    Action

    GE HealthCare will, without charge, remedy the defect or bring the product into compliance. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Us Nationwide-Worldwide Distribution

    Quantity

    180 units (60 US; 120 OUS)