BEUDAMED
    FDA Enforcement Class II Ongoing

    Senographe Pristina

    Recall: Z-0862-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0862-2024
    Event ID
    93837
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, SCS
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    December 26, 2023
    Classification Date
    February 8, 2024
    Address
    283 rue de la Miniere, Buc, N/A, 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.

    Code Info

    GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879

    Distribution

    Us Nationwide-Worldwide Distribution

    Quantity

    180 units (60 US; 120 OUS)