Ion Beam Applications S.A. — IBA Proton Therapy System - PROTEUS 235
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 3, 2026
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
What's affected?
- Product
- IBA Proton Therapy System - PROTEUS 235
- Lot code
- PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Additional details
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4 units (1 US, 3 OUS).
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