BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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-2715-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2715-2020
    Event ID
    86076
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2020
    Initiation Date
    July 17, 2020
    Classification Date
    July 27, 2020
    Termination Date
    August 30, 2021
    Address
    Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, N/A, Belgium

    Description

    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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

    IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

    Code Info

    Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019

    Distribution

    US: VA OUS: Belgium

    Quantity

    2 Units