BEUDAMED
    FDA Enforcement Class II Ongoing

    IBA Proton Therapy System - PROTEUS 235

    Recall: Z-1497-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1497-2026
    Event ID
    98364
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2026
    Initiation Date
    February 3, 2026
    Classification Date
    March 6, 2026
    Address
    Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, N/A, Belgium

    Description

    IBA Proton Therapy System - PROTEUS 235

    Reason

    It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.

    Code Info

    PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)

    Distribution

    Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.

    Quantity

    4 units (1 US, 3 OUS)