BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1009-2017 · Initiated December 21, 2016

    Recall

    Recall Number
    Z-1009-2017
    Event Number
    76028
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 21, 2016
    Terminated
    July 16, 2021
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    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.

    Action

    Elekta sent an Urgent Important Field Safety Notification letter dated December 2016 to customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice included a reply form to be returned to Elekta.

    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