IBA Proton Therapy System — Class II medical device recall Z-0295-2024
Ongoing recall by Ion Beam Applications S.A., reported 2023-11-22, distributed nationwide. The patient positioning system can perform motions in unexpected directions, creating the potential for crushi
| Recall number | Z-0295-2024 |
|---|---|
| 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 | 2023-09-18 |
| Classified | 2023-11-14 |
| Reported by FDA | 2023-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, ES, FR, IN, IT, NL, SG, TW |
| UPC / GTIN / UDI-DI | 05404013801138 |
| Serial numbers | SAT125, SAT127, SAT132, SAT133, SAT136, SAT140, SBF107, SBF112, SBF113, SBF117, SBF124, SBF125, SBF128, SBF135 |
Product
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Reason for recall
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
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-0295-2024. 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.