Ion Beam Applications S.A. recalls 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.

IBA Proton Therapy System - PROTEUS 235

On February 3, 2026 Urgent Medical Device Correction letters were sent to customers. Letter provides awareness of the Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. On-site modification of the devices will be performed by IBA with a TSS Configuration update. The update will be deployed at the impacted sites by June 2026.

• FDA enforcement recordOfficial FDA database entry for Z-1497-2026
• FDA 510(k) clearance · K163500The device's official FDA premarket clearance record
• FDA device classification · LHNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ion Beam Applications S.A.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.