BEUDAMED
    FDA Enforcement Class II Ongoing

    SIGNA Voyager, Nuclear Magnetic Resonance Imaging System

    Recall: Z-2062-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2062-2021
    Event ID
    88147
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    June 4, 2021
    Classification Date
    July 12, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    SIGNA Voyager, Nuclear Magnetic Resonance Imaging System

    Reason

    GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

    Distribution

    Worldwide distributions.

    Quantity

    541 devices