BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0885-2013 · Initiated January 18, 2013

    Recall

    Recall Number
    Z-0885-2013
    Event Number
    64213
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IXI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 18, 2013
    Posted
    February 26, 2013
    Terminated
    May 8, 2014
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.

    Distribution

    Nationwide Distribution including TX

    Quantity

    1