Proteus 235 Proton Therapy System Legacy Software version 7 — Class II medical device recall Z-1492-2014
Terminated recall by Ion Beam Applications S.A., reported 2014-04-30, distributed in IL, NJ, OK, WA. Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of
| Recall number | Z-1492-2014 |
|---|---|
| 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 | 2013-12-04 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2014-06-12 |
| Distributed | IL, NJ, OK, WA |
| Quantity | 4 |
| Model numbers | 110, 112, 113, 116 |
Product
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Reason for recall
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
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-1492-2014. 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.