BEUDAMED
    FDA Enforcement Class II Terminated

    Toshiba Kalare DREX-KL80 X-ray generator

    Recall: Z-1397-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1397-2017
    Event ID
    76175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    May 19, 2016
    Classification Date
    March 14, 2017
    Termination Date
    June 14, 2018
    Address
    PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    Toshiba Kalare DREX-KL80 X-ray generator

    Reason

    It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

    Code Info

    Model : KXO-80XD

    Distribution

    USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.

    Quantity

    254