[pending] IBA Proton Therapy System - PROTEUS 235
Pending LLM rewrite. Source: FDA_DEVICE Z-1497-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- IBA Proton Therapy System - PROTEUS 235
- Manufacturer
- Ion Beam Applications S.A.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- PROTEUS 235
- UDI-DI: 05404013801138
- Serial Numbers: SBF103 (JP)
- SBF124 (EU)
- SBF133 (US)
- SBF140 (EU)
Distribution
Distributed nationwide across the United States.
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