BEUDAMED
    FDA Recall Terminated

    Fuji Flash IIP and CR-IR346CL Consoles

    Recall: Z-0993-04 · Initiated May 5, 2004

    Recall

    Recall Number
    Z-0993-04
    Event Number
    29066
    Firm
    Fujifilm Medical System USA, Inc.
    FEI Number
    1000513161
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2004
    Posted
    July 20, 2004
    Terminated
    April 20, 2005
    Address
    419 West Ave, Stamford, CT, 06902-6300

    Description

    Fuji Flash IIP and CR-IR346CL Consoles

    Reason

    Software: Incorrect measurement of objects within a CR image

    Action

    FujiFilm Medical Systems issued notification letter dated 5/5/04 via Certified Mail. Units will be field corrected with a revised software by a service representative.

    Distribution

    Nationwide

    Quantity

    2602 units