IBA Proton Therapy System - PROTEUS 235 recall (Ion Beam Applications S.A.)
Medical deviceClass IIOngoing
Summary: Ion Beam Applications S.A. is recalling IBA Proton Therapy System - PROTEUS 235. Reason: 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 is being recalled
IBA Proton Therapy System - PROTEUS 235
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan. (states named: Florida)
How to tell if yours is affected
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1497-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 3, 2026 |
| Reported | March 18, 2026 |
| Company | Ion Beam Applications S.A. |
| Company location | Ottignies-Louvain-La-Neuve, N/A, Belgium |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4 units (1 US, 3 OUS) |
More recalls from Ion Beam Applications S.A. · all medical device recalls · recalls from February 2026