FDA-Device2026-03-18Class II

IBA Proton Therapy System - PROTEUS 235

Ion Beam Applications S.A.

Hazard

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.

Sold states

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

Affected count

4 units (1 US, 3 OUS)

Manufactured in

Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, Belgium

Products

IBA Proton Therapy System - PROTEUS 235

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2026

Original summary

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. 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. Affected quantity: 4 units (1 US, 3 OUS)

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