BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1599-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1599-2016
    Event ID
    73668
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    April 1, 2016
    Classification Date
    May 3, 2016
    Termination Date
    July 11, 2018
    Address
    419 West Ave, Stamford, CT, 06902-6343, United States

    Description

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

    Reason

    Reports of failure of the device's power supply.

    Code Info

    All serial numbers.

    Distribution

    Nationwide Distribution.

    Quantity

    2,062 devices