BEUDAMED
    FDA Enforcement Class II Ongoing

    LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

    Recall: Z-0157-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0157-2026
    Event ID
    97726
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 18, 2025
    Classification Date
    October 15, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

    Reason

    The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

    Code Info

    Model 5877533 UDI-DI: 00195278464637, Serial Numbers: LP9490416 LP9490175 LP9490393 LP9490399 LP9490376 LP9490463 LP9443017 LP9442472 LP9443231 LP9442094 LP9443291 LP9443230 LP9440403 LP9442483 LP9440972 LP9440166 LP9440237 LP9440933 LP9440348 LP9442196 LP9440631 LP9440926 LP9441099 LP9441225 LP9441097 LP9440929 LP9441030 LP9440921 LP9441035 LP9440507 LP9440920 LP9440459 LP9440460 LP9441332 LP9442656 LP9443022 LP9440986

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    37 units