BEUDAMED
    FDA Enforcement Class II Ongoing

    SIGNA PET/MR

    Recall: Z-2133-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2133-2025
    Event ID
    97030
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2025
    Initiation Date
    May 23, 2025
    Classification Date
    July 18, 2025
    Address
    3200 N Grandview Blvd, N/A, Waukesha, WI, 53188-1693, United States

    Description

    SIGNA PET/MR

    Reason

    GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

    Code Info

    GTIN: 00840682105378

    Distribution

    Worldwide distribution - US Nationwide and the country of China.

    Quantity

    N/A