Proteus 235 and Proteus ONE proton therapy systems — Class II medical device recall Z-2672-2017
Terminated recall by Ion Beam Applications S.A., reported 2017-07-12, distributed in FL, IL, LA, NJ, OK, PA, TN, TX…. Recall is being initiated to address on-site software installations not being performed consistently with IBA
| Recall number | Z-2672-2017 |
|---|---|
| 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 | 2016-05-18 |
| Classified | 2017-07-03 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2019-02-08 |
| Distributed | FL, IL, LA, NJ, OK, PA, TN, TX, VA, WA |
| Countries outside the US | CZ, DE, FR, IT, KR, PL, SE |
| Reason classes | software |
| Serial numbers | 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 and Proteus ONE proton therapy systems
Reason for recall
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
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-2672-2017. 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.