Official recall notice
FDA Recall: IBA Proton Therapy System - PROTEUS 235
- Recall date
- 2026-03-18
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
4 units (1 US, 3 OUS)
Product description
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.