IBA Proton Therapy System - PROTEUS 235
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.
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2026