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 | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). |
| Product | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy |
| Quantity | 4 |
| Distribution | US Distribution including the states of OK, IL, NJ, and WA. |
| Initiated | 2013-12-04 |
| Classified | 2014-04-24 |
| Terminated | 2014-06-12 |
| Recall number | Z-1492-2014 |
| 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-1492-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67678/
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