Proteus 235- designed to produce and deliver a proton beam for the… — Class II medical device recall Z-2434-2021
Ongoing recall by Ion Beam Applications S.A., reported 2021-09-15, distributed nationwide. Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information
| Recall number | Z-2434-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain-la-neuve, N/A, Belgium |
| Recall initiated | 2021-06-14 |
| Classified | 2021-09-10 |
| Reported by FDA | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, FR, GB, IN, IT, JP, RU, SE |
| Quantity | 27 worldwide |
Product
Proteus 235- 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
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
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-2434-2021. 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.