Recall Z-2693-2024 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 | Aug 21, 2024 (initiated Jul 10, 2024) |
| Status | Open, Classified |
| Reason | Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues |
| Root cause | Process design |
| Action | IBA isued Urgent Medical Device Correction letter on July 10, 2024. Letter states reason for recall, health risk and action to take: IBA would like to remind you as IBA Proton Therapy System -PROTEUS 235 user of the warnings present in your Clinical User's Guide which emphasize the importance of carefully monitoring the patients behavior during the different treatment phases. IBA would like to also remind you that the manual hand crank could be used by the system operator for the emergency release of the Patient Positioning System in the situations listed in the Clinical User's Guide and Accel |
| Quantity | 19 units |
| Distribution | IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden |
| 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 |