BEUDAMED
    FDA Enforcement Class II Terminated

    Focal SIM Planning of radiation therapy

    Recall: Z-2002-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-2002-2012
    Event ID
    62433
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    July 18, 2012
    Initiation Date
    June 21, 2012
    Classification Date
    July 12, 2012
    Termination Date
    April 1, 2014
    Address
    4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, 30092-3011, United States

    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.

    Code Info

    Version 4.64.00 - 4.700, inclusive

    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