BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

    Recall: Z-2029-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2029-2025
    Event ID
    96992
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems China Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2025
    Initiation Date
    May 16, 2025
    Classification Date
    June 26, 2025
    Address
    Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, N/A, China

    Description

    GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

    Reason

    GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

    Code Info

    UDI/DI 00195278722430, Lot/Serial Numbers: 6310028WX0, 6310008WX0, 6310041WX0, 6310017WX0, 6310031WX0, 6310044WX0, 6310024WX0, 6310038WX0, 6310040WX0, 6310019WX0, 6310018WX0, 6310023WX0, 6310033WX0, 6310012WX0, 6310026WX0, 6310020WX0, 6310032WX0, 6310014WX0, 6310021WX0, 6310025WX0, 6310010WX0, 6310027WX0, 6310037WX0, 6310009WX0, 6310007WX0, 6310035WX0, 6310016WX0, 6310039WX0, 6310036WX0, 6310043WX0, 6310011WX0, 6310015WX0, 6310013WX0, 6310029WX0.

    Distribution

    Worldwide distribution.

    Quantity

    34 units