IBA Proton Therapy System - PROTEUS 235 recall
IBA Proton Therapy System - PROTEUS 235
Why was IBA Proton Therapy System - PROTEUS 235 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
- Product
- IBA Proton Therapy System - PROTEUS 235
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 4 units (1 US, 3 OUS)
- Distribution
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
- Recall date
- March 18, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)