BEUDAMED
    FDA Recall Terminated

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    Recall: Z-2157-2013 · Initiated August 15, 2013

    Recall

    Recall Number
    Z-2157-2013
    Event Number
    66048
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IXI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 15, 2013
    Posted
    September 4, 2013
    Terminated
    July 28, 2015
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    Reason

    Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

    Action

    Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.

    Distribution

    Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.

    Quantity

    31