IBA Proton Therapy System - PROTEUS 235

Class II

Recalling firm: Ion Beam Applications S.A.
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.
Distribution pattern: Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
State: N/A
Status: Ongoing
Recall number: Z-1497-2026
Recall initiated: February 3, 2026