FDA Device recall Z-0466-2022
Proteus 235
- FDA Device
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of Proteus 235 by Ion Beam Applications, citing 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). Initiati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0466-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-29 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ion Beam Applications |
| Distribution | IN, NJ, OK, TN, VA |
Product
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
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.
Identifiers
| code_info | PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0466-2022%22
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