IBA proton therapy system may not interrupt beam when gating fails
Ion Beam Applications is recalling PROTEUS 235 proton therapy systems because a disabled interface means the safety system may not interrupt beam delivery if the external gating signal is lost.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source describes a risk of mistreatment if the gating signal is lost, and no injuries are stated.
Plain-English summary
Ion Beam Applications S.A. is recalling the IBA Proton Therapy System PROTEUS 235. Four units were distributed, one in Florida and three outside the United States, in Italy and Japan. The FDA has classified this recall as Class II.
The Universal Beam Triggering Interface was identified as disabled in the Therapy Safety System configuration. In this condition, the Therapy Safety System 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.
Affected systems carry UDI-DI 05404013801138, with serial numbers SBF103, SBF124, SBF133 and SBF140.
Facilities can identify affected systems by the model and serial numbers above, and may contact Ion Beam Applications S.A. for further information.
The recalled product
- Product
- IBA Proton Therapy System - PROTEUS 235
- Manufacturer
- Ion Beam Applications S.A.
- Category
- Medical Device — Radiotherapy
- Hazard
- safety-interlock-disabled
- mistreatment-risk
- configuration-error
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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