Proteus 235 — Class II medical device recall Z-2592-2017
Terminated recall by Ion Beam Applications S.A., reported 2017-06-28, distributed in FL, IL, LA, MA, NJ, PA, TN, TX…. It has been observed during testing that there could be clinically non-negligible amount of dark current (a we
| Recall number | Z-2592-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain La Neuve, Belgium |
| Recall initiated | 2017-02-09 |
| Classified | 2017-06-19 |
| Reported by FDA | 2017-06-28 |
| Terminated | 2023-07-14 |
| Distributed | FL, IL, LA, MA, NJ, PA, TN, TX, VA, WA |
| Countries outside the US | CZ, DE, FR, IT, KR, PL, SE |
| Quantity | 18 systems |
| Serial numbers | PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126 |
Product
Proteus 235
Reason for recall
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.
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-2592-2017. 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.