Proteus 235 — Class II medical device recall Z-2424-2018
Terminated recall by Ion Beam Applications S.A., reported 2018-07-18, distributed nationwide. Correction vector confirmation message is lost if access point is changed after sending the correction vector.
| Recall number | Z-2424-2018 |
|---|---|
| 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 | 2018-05-16 |
| Classified | 2018-07-11 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2018-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL, SE |
| Quantity | 3 units |
| Serial numbers | SAT.122 |
Product
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for recall
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
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-2424-2018. 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.