Proteus 235 — Class II medical device recall Z-0466-2022
Terminated recall by Ion Beam Applications S.A., reported 2022-01-19, distributed in NJ, OK, TN, VA. Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some pro
| Recall number | Z-0466-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain-la-neuve, N/A, Belgium |
| Recall initiated | 2021-11-29 |
| Classified | 2022-01-07 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2024-02-20 |
| Distributed | NJ, OK, TN, VA |
| Countries outside the US | CZ |
| Quantity | 5 devices |
| Reason classes | software |
Product
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0466-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.