BEUDAMED
    FDA Recall Open, Classified

    GE Healthcare Vivid S60N, ultrasound device

    Recall: Z-2126-2023 · Initiated May 30, 2023

    Recall

    Recall Number
    Z-2126-2023
    Event Number
    92505
    Firm
    GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway
    FEI Number
    3002808457
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 30, 2023
    Posted
    July 10, 2023

    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.

    Action

    GE Healthcare sent an Urgent Medical Device Correction notice to its consignees on 05/30/2023 by mail (traceable means). The notice explained the problem with the instrument and provided the following: "You can continue to use your device. Please follow clinical practice guidelines, which include having a backup imaging plan when performing time-critical examinations or image-guided interventions." The devices will be corrected at no charge to the consignee.

    Distribution

    Worldwide distribution.