BEUDAMED
    FDA Recall Terminated

    Focal SIM Planning of radiation therapy

    Recall: Z-2002-2012 · Initiated June 21, 2012

    Recall

    Recall Number
    Z-2002-2012
    Event Number
    62433
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 21, 2012
    Posted
    July 12, 2012
    Terminated
    April 1, 2014
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Focal SIM Planning of radiation therapy

    Reason

    Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

    Action

    IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.

    Distribution

    Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.

    Quantity

    38 units