WhichRecall
Class IIReported 2026-03-18

IBA Proton Therapy System - PROTEUS 235

Recalled by Ion Beam Applications S.A.

Reason for Recall

It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration

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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.

Recall Number
Z-1497-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-02-03
Reported
2026-03-18
Distribution
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Code Info
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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