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 | It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers. |
| Product | Proteus 235 |
| Quantity | 18 systems ( 10 in the US) |
| Distribution | Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden. |
| Initiated | 2017-02-09 |
| Classified | 2017-06-19 |
| Terminated | 2023-07-14 |
| Recall number | Z-2592-2017 |
| 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-2592-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77175/
Alerts for ION BEAM APPLICATIONS S.A.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.