BEUDAMED
    FDA Enforcement Class II Terminated

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Recall: Z-1009-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1009-2017
    Event ID
    76028
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    December 21, 2016
    Classification Date
    January 11, 2017
    Termination Date
    July 16, 2021
    Address
    400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227, United States

    Description

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Reason

    Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

    Code Info

    Software Versions 5.00 and higher

    Distribution

    Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey

    Quantity

    279