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 | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. |
| Product | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) |
| Quantity | 2 |
| Distribution | Units were distributed to Korea and Jacksonville, FL. |
| Initiated | 2016-04-11 |
| Classified | 2018-06-23 |
| Terminated | 2020-03-25 |
| Recall number | Z-2284-2018 |
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-2284-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80217/
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