FDA DevicesClass II
IBA Proton Therapy System - PROTEUS 235
Published: March 18, 2026Recall ID: Z-1497-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
IBA Proton Therapy System - PROTEUS 235
Additional Source Details
| Field | Value |
|---|---|
| City | Ottignies-Louvain-La-Neuve |
| State | N/A |
| Event id | 98364 |
| Address 1 | Chemin Du Cyclotron 3 |
| Address 2 | N/A |
| Code info | PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU) |
| Postal code | N/A |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 4 units (1 US, 3 OUS) |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260203 |
| Initial firm notification | Letter |
| Center classification date | 20260306 |
Overview
- Recalling FirmIon Beam Applications S.A.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.