Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235

Recall date

February 3, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1497-2026

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IBA Proton Therapy System - PROTEUS 235