BEUDAMED
    FDA Recall Terminated

    Monaco Radiation Treatment Planning (RTP) System

    Recall: Z-0965-2019 · Initiated February 8, 2019

    Recall

    Recall Number
    Z-0965-2019
    Event Number
    82072
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 8, 2019
    Terminated
    August 19, 2024
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco Radiation Treatment Planning (RTP) System

    Reason

    If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

    Action

    Elekta notified customers on about 2/08/2019 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION." Instructions included to ensure the optimization model is set to "Reproduce Goal Dose" when creating a completion plan. Customers were also requested to post the recall notice in an accessible place for all users to see, advise the appropriate personnel working with the device of the recall, and to complete and return the Acknowledgement Form. The issue will be resolved in Monaco release 5.40.01.

    Distribution

    Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

    Quantity

    14 devices