BEUDAMED
    FDA Enforcement Class II Terminated

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Recall: Z-1088-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1088-2015
    Event ID
    70279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    January 7, 2015
    Classification Date
    February 10, 2015
    Termination Date
    April 14, 2016
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    Reason

    Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

    Code Info

    153602, 153538, 153561, 153569, 153532, 153556, 153566, 153563, 153564, 153589, 153530, 153531, 153562, 153584, 153615, 153534, 153534, 153535, 153563, 153542, 153542, 153548, 153548, 153558, 153578, 153595, 153699, 153630, 153728, 153680, 153712. 153717, 153723, 153734, 153702, 153715, 153684, 153710, 153577, 153725, 153726, 153691, 153696, 153713, 153724, 153727

    Distribution

    Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.

    Quantity

    46