BEUDAMED
    FDA Recall Terminated

    Fujifilm FDR Go Plus mobile X-ray system

    Recall: Z-2441-2019 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2441-2019
    Event Number
    83524
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 19, 2019
    Terminated
    August 28, 2020
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    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)

    Action

    Fuji Film issued notifications via FedEx standard overnight mail on July 19, 2019 advising of the problem, health risk and action to take: During this field action, you can continue to use your current FDR Go PLUS by following these additional instructions:1. Set the monitor sleep mode to Off. Complete the Field Action Verification Form, and upon receipt FUJIFILM service personnel will contact you to schedule a visit to correct your device.FUJIFILM will correct your affected device(s) by applying a registry file to your current software version, at no cost to you.. Question contact: Field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email mailto:[email protected]

    Distribution

    Nationwide

    Quantity

    174 units