BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

    Recall: Z-2316-2024 · Reported July 17, 2024

    Enforcement

    Recall Number
    Z-2316-2024
    Event ID
    94772
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Vingmed Ultrasound As
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2024
    Initiation Date
    May 2, 2024
    Classification Date
    July 5, 2024
    Address
    Strandpromenaden 45, N/A, Horten, N/A, N/A, Norway

    Description

    GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

    Reason

    GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.

    Code Info

    a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002

    Distribution

    US: IL, MA, NM, NY, OK,

    Quantity

    7 units