BEUDAMED
    FDA Enforcement Class II 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 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2424-2018
    Event ID
    80298
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    May 16, 2018
    Classification Date
    July 11, 2018
    Termination Date
    October 16, 2018
    Address
    Chemin du Cyclotron, 3, Louvain La Neuve, N/A, 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.

    Code Info

    Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)

    Distribution

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

    Quantity

    3 units