BEUDAMED
    FDA Recall Terminated

    Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Recall: Z-2424-2018 · Initiated May 16, 2018

    Recall

    Recall Number
    Z-2424-2018
    Event Number
    80298
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 16, 2018
    Posted
    June 20, 2018
    Terminated
    October 16, 2018
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium

    Description

    Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Reason

    Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

    Action

    On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement. Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application. A software update will be deployed on all affected sites by July 2018. Customers with questions may email: [email protected]

    Distribution

    Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands

    Quantity

    3 units