Medical Device Recall: IBA Proton Therapy System - PROTEUS 235
Ion Beam Applications S.A. · February 3, 2026
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
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
States Affected
NATIONWIDE
Quantity Affected
4 units (1 US, 3 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1497-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.