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Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235
Recalled March 18, 2026 · FDA recall Z-1497-2026 · Ion Beam Applications S.A
Hazard
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. · FDA Class II
Units
4 units (1 US, 3 OUS)
Sold at
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Description
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.
Product
IBA Proton Therapy System - PROTEUS 235
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →