BEUDAMED
    FDA Enforcement Class II Terminated

    Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

    Recall: Z-1040-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1040-2019
    Event ID
    82187
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 27, 2019
    Initiation Date
    January 15, 2019
    Classification Date
    March 21, 2019
    Termination Date
    October 8, 2020
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

    Reason

    FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.

    Code Info

    Serial Numbers: MQ0001281001 through MQ0001285004

    Distribution

    US Nationwide Distribution

    Quantity

    56 units