Proteus 235 The PTS is a medical device designed to produce and… — Class II medical device recall Z-2173-2018
Terminated recall by Ion Beam Applications S.A., reported 2018-06-20. IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians dur
| Recall number | Z-2173-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Louvain La Neuve, N/A, Belgium |
| Recall initiated | 2016-08-07 |
| Classified | 2018-06-12 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-03-25 |
| Countries outside the US | CZ, DE, FR, IT, KR, PL, SE |
| Quantity | 19 units |
| Serial numbers | PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126 |
Product
Proteus 235 The PTS 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
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
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-2173-2018. 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.