IBA Proton Therapy System — Class II medical device recall Z-1945-2024
Ongoing recall by Ion Beam Applications S.A., reported 2024-06-12, distributed nationwide. Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the
| Recall number | Z-1945-2024 |
|---|---|
| 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 | 2024-05-10 |
| Classified | 2024-06-03 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 05404013801138, 05404013814015 |
| Serial numbers | PTS-11, SAT136, SAT140 |
Product
IBA Proton Therapy System - PROTEUS 235 - 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
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
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-1945-2024. 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.