BEUDAMED
    FDA Recall Open, Classified

    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

    Recall: Z-2560-2019 · Initiated September 4, 2019

    Recall

    Recall Number
    Z-2560-2019
    Event Number
    83692
    Firm
    Elekta Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 4, 2019
    Address
    13723 Riverport Dr, Ste 100, Maryland Heights, MO, 63043-4819

    Description

    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

    Reason

    It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

    Action

    The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.

    Distribution

    Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK

    Quantity

    30 units