BEUDAMED
    FDA Enforcement Class II Ongoing

    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

    Recall: Z-1603-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1603-2024
    Event ID
    94297
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 1, 2024
    Initiation Date
    March 4, 2024
    Classification Date
    April 19, 2024
    Address
    Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, N/A, Belgium

    Description

    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

    Reason

    There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

    Code Info

    PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.

    Distribution

    US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.

    Quantity

    8 units