Proteus 235 Product Usage: The Proton Therapy System — Class II medical device recall Z-0698-2019
Terminated recall by Ion Beam Applications S.A., reported 2019-01-16, distributed nationwide. There is a risk of detachment of the Compact Gantry Rolling Floor.
| Recall number | Z-0698-2019 |
|---|---|
| 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 | 2018-12-12 |
| Classified | 2019-01-08 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-04-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, GB, JP |
| Quantity | 7 |
| Reason classes | device malfunction |
Product
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason for recall
There is a risk of detachment of the Compact Gantry Rolling Floor.
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-0698-2019. 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.