BEUDAMED
    FDA Recall Terminated

    Monaco Radiation Treatment Planning System (RTP) System

    Recall: Z-2409-2019 · Initiated August 23, 2019

    Recall

    Recall Number
    Z-2409-2019
    Event Number
    83604
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 23, 2019
    Terminated
    June 28, 2024
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco Radiation Treatment Planning System (RTP) System

    Reason

    Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

    Action

    Elekta Inc. notified customers on about 08/23/2019 via "IMPORTANT FIELD SAFETY NOTIFICATION" letter. The letter informed customers that the Monaco is displaying some incorrect shift information on the Scan and Setup Reference Report and is DICOM exporting incorrect shift information. Instructions included that all shifts should be verified before treatment, that a software fix is planned. Customer were also instructed to post the notice in a place accessible to all users, advise personnel working with the device of the issue, and to complete and return the Acknowledgement Form provided.

    Distribution

    Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.

    Quantity

    49 units