BEUDAMED
    FDA Enforcement Class II Ongoing

    Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

    Recall: Z-0875-2026 · Reported December 17, 2025

    Enforcement

    Recall Number
    Z-0875-2026
    Event ID
    98081
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    December 17, 2025
    Initiation Date
    October 24, 2025
    Classification Date
    December 9, 2025
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

    Reason

    Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

    Code Info

    GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026

    Distribution

    U.S. and OUS.

    Quantity

    1,818 (1,580 US; 238 OUS)