BEUDAMED
    FDA Recall 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 · Initiated January 15, 2019

    Recall

    Recall Number
    Z-1040-2019
    Event Number
    82187
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 15, 2019
    Terminated
    October 8, 2020
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    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.

    Action

    Fujifilm sent an Urgent Medical Device Correction and Removal letter dated January 16, 2019 to customers. The letter identified the affected product, problem and actions to be taken. Customers were advised to schedule a visit by our Service department to replace the handle assembly. Customers were provided with additional instructions to continue using the affected product safely until the correction was made. For questions call 201-675-8947.

    Distribution

    US Nationwide Distribution

    Quantity

    56 units