Ion Beam Applications S.A.
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Ion Beam Applications S.A. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-18FDA-DeviceClass IIIBA 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.
- 2024-09-18FDA-DeviceClass IIIBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
- 2024-08-28FDA-DeviceClass IIIBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
- 2024-06-12FDA-DeviceClass IIIBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
- 2024-05-01FDA-DeviceClass IIIBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
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