Reported Mar 18, 2026 · Ongoing
IBA Proton Therapy System - PROTEUS 235
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin Du Cyclotron 3 · Ottignies-Louvain-La-Neuve, N/A · N/A
Is this the product you have?
- IBA Proton Therapy System - PROTEUS 235
- Lot codes and dates
- PROTEUS 235
- UDI-DI05404013801138
- Serial Numbers
SBF103 (JP)SBF124 (EU)SBF133 (US)SBF140 (EU)
- Amount recalled
- 4 units (1 US, 3 OUS)
Where it was sold
- Nationwide
- FL
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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