Proteus ONE and Proteus Plus — Class II medical device recall Z-2139-2018
Terminated recall by Ion Beam Applications S.A., reported 2018-06-20. IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party e
| Recall number | Z-2139-2018 |
|---|---|
| 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 | 2016-09-16 |
| Classified | 2018-06-08 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-02-08 |
| Countries outside the US | CZ, DE, FR, IT, KR, PL, SE |
| 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, SBF.101 |
Product
Proteus ONE and Proteus Plus
Reason for recall
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
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-2139-2018. 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.