BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0875-2026 · Initiated October 24, 2025

    Recall

    Recall Number
    Z-0875-2026
    Event Number
    98081
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    MUE
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 24, 2025
    Posted
    December 9, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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).

    Action

    GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label.

    Distribution

    U.S. and OUS.

    Quantity

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