Recall Z-1945-2024 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
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.
| Date | Jun 3, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances |
| Root cause | Device Design |
| Action | 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 DIF |
| Quantity | 2 units |
| Distribution | Worldwide - US Nationwide distribution in the state of Virginia and the country of India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., Aug 17, 2017 |