BEUDAMED
    FDA Recall Terminated

    Monaco RTP System. Radiation treatment planning.

    Recall: Z-0841-2013 · Initiated February 11, 2013

    Recall

    Recall Number
    Z-0841-2013
    Event Number
    64328
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 11, 2013
    Posted
    February 20, 2013
    Terminated
    January 21, 2014
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco RTP System. Radiation treatment planning.

    Reason

    The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

    Action

    Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.

    Distribution

    Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

    Quantity

    13