BEUDAMED
    FDA Enforcement Class II Terminated

    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

    Recall: Z-0885-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0885-2013
    Event ID
    64213
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    March 6, 2013
    Initiation Date
    January 18, 2013
    Classification Date
    February 26, 2013
    Termination Date
    May 8, 2014
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

    Reason

    If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

    Code Info

    152652

    Distribution

    Nationwide Distribution including TX

    Quantity

    1