Proton therapy system -Proteus 235 aka Proteus Plus — Class II medical device recall Z-2097-2017
Terminated recall by Ion Beam Applications S.A., reported 2017-05-24, distributed in FL. A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may resta
| Recall number | Z-2097-2017 |
|---|---|
| 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 | 2017-04-10 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2018-02-16 |
| Distributed | FL |
| Quantity | 2 |
| Serial numbers | PAT.003, PAT.006 |
Product
Proton therapy system -Proteus 235 aka Proteus Plus. 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.
Reason for recall
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
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-2097-2017. 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.