BEUDAMED
    FDA Recall Terminated

    Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

    Recall: Z-1599-2016 · Initiated April 1, 2016

    Recall

    Recall Number
    Z-1599-2016
    Event Number
    73668
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    IXW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 1, 2016
    Terminated
    July 11, 2018
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

    Reason

    Reports of failure of the device's power supply.

    Action

    Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.

    Distribution

    Nationwide Distribution.

    Quantity

    2,062 devices