IBA Proton Therapy System PROTEUS 235
IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.
Contact IBA immediately to verify whether your PROTEUS 235 system is affected and obtain a corrected TSS configuration that re-enables the Universal Beam Triggering Interface.
Why it was recalled
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 to identify it
UPC 05404013801138
IBA Proton Therapy System - PROTEUS 235
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification