BEUDAMED
    FDA Recall Terminated

    Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.

    Recall: Z-0014-2012 · Initiated May 25, 2011

    Recall

    Recall Number
    Z-0014-2012
    Event Number
    59949
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 25, 2011
    Terminated
    January 14, 2014
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.

    Reason

    It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).

    Action

    Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.

    Distribution

    Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.

    Quantity

    27