IBA Proton Therapy System - PROTEUS 235
FDA Recall #Z-1497-2026 — Class II — February 3, 2026
Product Description
IBA Proton Therapy System - PROTEUS 235
Reason for Recall
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.
Recalling Firm
Ion Beam Applications S.A. — Ottignies-Louvain-La-Neuve, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4 units (1 US, 3 OUS)
Distribution
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Code Information
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated