IBA Proton Therapy System — Class II medical device recall Z-1603-2024
Ongoing recall by Ion Beam Applications S.A., reported 2024-05-01, distributed nationwide. There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of toleran
| Recall number | Z-1603-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ion Beam Applications S.A., Ottignies-Louvain-La-Neuve, N/A, Belgium |
| Recall initiated | 2024-03-04 |
| Classified | 2024-04-19 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 05404013801138 |
| Serial numbers | SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135 |
Product
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Reason for recall
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
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-1603-2024. 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.