Proteus 235 Proton Therapy System for cancer treatment — Class II medical device recall Z-0020-2015
Terminated recall by Ion Beam Applications S.A., reported 2014-11-05, distributed nationwide. While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio
| Recall number | Z-0020-2015 |
|---|---|
| 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 | 2014-03-27 |
| Classified | 2014-10-29 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2014-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, DE, IT |
| Quantity | 8 |
Product
Proteus 235 Proton Therapy System for cancer treatment.
Reason for recall
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
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-0020-2015. 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.