IBA Proton Therapy System - PROTEUS 235
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 03, 2026 |
| Reported | March 18, 2026 |
| Recalling firm | Ion Beam Applications S.A. |
| Country / region | Belgium N/A |
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.
Affected products
- IBA Proton Therapy System - PROTEUS 235
Related recalls
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