BEUDAMED
    FDA Recall Open, Classified

    IBA Proton Therapy System - PROTEUS 235

    Recall: Z-1497-2026 · Initiated February 3, 2026

    Recall

    Recall Number
    Z-1497-2026
    Event Number
    98364
    Firm
    Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 3, 2026
    Posted
    March 6, 2026

    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.

    Action

    On February 3, 2026 Urgent Medical Device Correction letters were sent to customers. Letter provides awareness of the Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. On-site modification of the devices will be performed by IBA with a TSS Configuration update. The update will be deployed at the impacted sites by June 2026.

    Distribution

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

    Quantity

    4 units (1 US, 3 OUS)