BEUDAMED
    FDA Enforcement Class II Terminated

    Monaco RTP System. Radiation treatment planning.

    Recall: Z-0841-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0841-2013
    Event ID
    64328
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    February 11, 2013
    Classification Date
    February 20, 2013
    Termination Date
    January 21, 2014
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States

    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.

    Code Info

    Versions 3.20.00 and 3.20.01

    Distribution

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

    Quantity

    13