BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2284-2018 · Initiated April 11, 2016

    Recall

    Recall Number
    Z-2284-2018
    Event Number
    80217
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    April 11, 2016
    Terminated
    March 25, 2020
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve 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.

    Action

    IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue.

    Distribution

    Units were distributed to Korea and Jacksonville, FL.

    Quantity

    2