Proteus 235 — Class II medical device recall Z-0938-2018
Terminated recall by Ion Beam Applications S.A., reported 2018-03-21. There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
| Recall number | Z-0938-2018 |
|---|---|
| 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 | 2017-11-17 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2021-06-14 |
| Quantity | 37 |
Product
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for recall
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
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-0938-2018. 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.