BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235 Product Usage: 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    Recall: Z-0698-2019 · Reported January 16, 2019

    Enforcement

    Recall Number
    Z-0698-2019
    Event ID
    81807
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2019
    Initiation Date
    December 12, 2018
    Classification Date
    January 8, 2019
    Termination Date
    April 15, 2020
    Address
    Chemin Du Cyclotron 3, Louvain-la-neuve, N/A, Belgium

    Description

    Proteus 235 Product Usage: 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    Reason

    There is a risk of detachment of the Compact Gantry Rolling Floor.

    Code Info

    SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109

    Distribution

    Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.

    Quantity

    7