BEUDAMED
    FDA Enforcement Class II Ongoing

    Monaco RTP System, 5.50/5.51, 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-2561-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2561-2019
    Event ID
    83692
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 2, 2019
    Initiation Date
    September 4, 2019
    Classification Date
    September 25, 2019
    Address
    13723 Riverport Dr Ste 100, Maryland Heights, MO, 63043-4819, United States

    Description

    Monaco RTP System, 5.50/5.51, 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.

    Code Info

    UDI: (01)00858164002244(10) 5.50.00 (01)00858164002268(10) 5.51.00

    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

    49 units