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FDA DeviceClass IINotable

FDA Recall: IBA Proton Therapy System - PROTEUS 235

Date: 2026-03-18
Brand: Ion Beam Applications S.A.
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

4 units (1 US, 3 OUS)

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