Class II — Ion Beam Applications S.A.
| Recalling firm | ION BEAM APPLICATIONS S.A. |
|---|---|
| Registered facility | ION BEAM APPLICATIONS S.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 |
| Quantity | 5 devices |
| Distribution | IN USA: VA, OK, NJ, TN OUS: Czech Republic. |
| Initiated | 2021-11-29 |
| Classified | 2022-01-07 |
| Terminated | 2024-02-20 |
| Recall number | Z-0466-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ion Beam Applications S.A. (Z-0466-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89267/
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