BEUDAMED
    FDA Recall Terminated

    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

    Recall: Z-1642-2014 · Initiated June 29, 2012

    Recall

    Recall Number
    Z-1642-2014
    Event Number
    67958
    Firm
    Fujifilm Medical System USA, Inc.
    FEI Number
    1000513161
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 29, 2012
    Posted
    May 21, 2014
    Terminated
    June 1, 2018
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

    Reason

    The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.

    Action

    Fujifilm will replace the violative labels with replacement labels provided by DRGEM, to bring the X-ray generator into compliance. You stated that you expect for all nine installed units to be corrected by the end of May 2014. The seven units in the Stamford, CT warehouse will be corrected when the generators are delivered to customer sites. Under 21 CFR 1003.31(c)(2), this exemption is granted subject to the following conditions: 1. You must correct the missing certification statement for all units shipped into the US within the timeline you specified, by the end of May 2014. 2. You must ensure that all future units that will be delivered and installed in the US will be in compliance with the labeling requirement, per 21 CFR 1010.2.

    Distribution

    Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.

    Quantity

    14