Ion Beam Applications S.A. Recall 95080
Description: IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Ion Beam Applications S.A. Recall 95080 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3089-2024 |
| Event ID | 95080 |
| Event Description | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions |
| Product Type | Devices |
| 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. |
| Quantity | 35 units |
| Recall Reason | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime |
| Device Classification | 20240918 |
| Device Code Info | UDI-DI: 05404013801138 Serial Numbers: PAT.107 (DE), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (NL), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.112 (BE), SBF.113 (US), SBF.117 (ES), SBF.124 (IT), SBF.125 (SG), SBF.128 (US), SBF.135 (US). |
| Center Classification Date | 20240910 |
| Recall Initiation Date | 20240708 |
| Recalling Firm | Ion Beam Applications S.A. |
| Initial Notification | Letter |
| Similar To |