IBA 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

Iba issued Urgent Medical Device Correction Letter on May 10, 2024 via IBA responsible directly to customer site either by hand or by email. Letter states reason for recall, health risk and action to take: ACTION BEING TAKEN BY IBA Monitoring of the deflector, software upgrade. 7.2 CORRECTIVE ACTIONS Software upgrade 7.3 PREVENTIVE ACTIONS Waiting for the solution to be deployed, IBA will distribute an Internal User Notice to IBA operators of impacted sites with instructions to monitor the deflector and stop the irradiation when necessary. 7.4 TIME SCHEDULE FOR THE IMPLEMENTATION OF THE DIFFERENT ACTIONS The Internal User Notice will be provided to IBA operators by May 10, 2024. The corrective action will be implemented at your site by June 2025. Contact: Sonia PINEL [email protected]