BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235, Proton Therapy System

    Recall: Z-1830-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1830-2017
    Event ID
    76804
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 21, 2017
    Classification Date
    April 17, 2017
    Termination Date
    September 19, 2018
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus 235, Proton Therapy System

    Reason

    In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

    Code Info

    Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

    Distribution

    Distribution in US (to Louisiana), and France.

    Quantity

    2 worldwide, 1 in U.S.