BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Healthcare Vivid S60N, ultrasound device

    Recall: Z-2126-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2126-2023
    Event ID
    92505
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Vingmed Ultrasound As
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2023
    Initiation Date
    May 30, 2023
    Classification Date
    July 10, 2023
    Address
    Strandpromenaden 45, N/A, Horten, N/A, N/A, Norway

    Description

    GE Healthcare Vivid S60N, ultrasound device

    Reason

    GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

    Code Info

    Software versions: v203, v204, v205, v206

    Distribution

    Worldwide distribution.

    Quantity

    N/A