BEUDAMED
    FDA Enforcement Class II Terminated

    Fujifilm FDR Go Plus mobile X-ray system

    Recall: Z-2441-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2441-2019
    Event ID
    83524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 19, 2019
    Classification Date
    August 30, 2019
    Termination Date
    August 28, 2020
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    Fujifilm FDR Go Plus mobile X-ray system

    Reason

    The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)

    Code Info

    All serial numbers

    Distribution

    Nationwide

    Quantity

    174 units