Recall Z-3089-2024 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
| Date | Sep 10, 2024 (initiated Jul 8, 2024) |
| Status | Open, Classified |
| Reason | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime |
| Root cause | Under Investigation by firm |
| Action | IBA issued AMENDED Urgent Medical Device Correction letter (IBA REFERENCE NCIPT-27531) on 7/10/24 provided by IBA directly to the customer either by hand or by email. Letter states reason for recall, health risk and action to take: Regarding Proteus 235 with a PTS-8, PTS-10, PTS-11 or PTS-12 versions: actions: Regarding the malfunction of Safety Parameters Verification Mechanism within BAPP . IBA carried out an analysis to determine if the impacted sites have some safety parameters checked by the BAPP in their clinical site configuration with values leading to violations. The result of this a |
| Quantity | 35 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW. |
| 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 |