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Ion Beam Applications S.A.: IBA Proton Therapy System - PROTEUS 235

Medical DevicesSource: FDA (device) · Date: 2026-03-18

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Ion Beam Applications S.A.
Product
IBA Proton Therapy System - PROTEUS 235
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Recall initiated
2026-02-03
Code info
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Product quantity
4 units (1 US, 3 OUS)
Voluntary mandated
Voluntary: Firm initiated
City
Ottignies-Louvain-La-Neuve
State
N/A
Country
Belgium
Event id
98364
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