BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1642-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1642-2014
    Event ID
    67958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical System USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2014
    Initiation Date
    June 29, 2012
    Classification Date
    May 21, 2014
    Termination Date
    June 1, 2018
    Address
    419 West Ave, N/A, Stamford, CT, 06902-6343, United States

    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.

    Code Info

    SN: MXA1170108, MXA1270262

    Distribution

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

    Quantity

    14