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Medical Device

IBA Proton Therapy System - PROTEUS 235

Recall date: 2026-03-18 · Source: FDA_DEVICE
Brand / Firm
Ion Beam Applications S.A.
Product
IBA Proton Therapy System - PROTEUS 235
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.
Units affected
4 units (1 US, 3 OUS)
Description
IBA Proton Therapy System - PROTEUS 235
View official recall notice →