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.
- 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.
- 2023-11-22FDA-DeviceClass IIIBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
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