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Recall Observatory FDA recall evidence

Device product

IBA Proton Therapy System - PROTEUS 235

Z-1497-2026

February 03, 2026

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 98364
Status
Ongoing
Classification
Class II
Quantity
4 units (1 US, 3 OUS)
Official record key
device-enforcement:Z-1497-2026

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.