BEUDAMED
    FDA Enforcement Class II Terminated

    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

    Recall: Z-2284-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2284-2018
    Event ID
    80217
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    April 11, 2016
    Classification Date
    June 23, 2018
    Termination Date
    March 25, 2020
    Address
    Chemin du Cyclotron, 3, Louvain La Neuve, N/A, Belgium

    Description

    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

    Reason

    IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

    Code Info

    PAT.003 and PAT.006

    Distribution

    Units were distributed to Korea and Jacksonville, FL.

    Quantity

    2