Ion Beam Applications S.A. Recall 89267
Description: Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Ion Beam Applications S.A. Recall 89267 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0466-2022 |
| Event ID | 89267 |
| Event Description | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 |
| Product Type | Devices |
| Distribution | IN USA: VA, OK, NJ, TN OUS: Czech Republic. |
| Quantity | 5 devices |
| Recall Reason | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments. |
| Device Classification | 20220119 |
| Device Code Info | PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US). |
| Center Classification Date | 20220107 |
| Recall Initiation Date | 20211129 |
| Recalling Firm | Ion Beam Applications S.A. |
| Initial Notification | Letter |
| Similar To |