IBA Proton Therapy System — Class II medical device recall Z-1497-2026
Ongoing recall by Ion Beam Applications S.A., reported 2026-03-18, distributed nationwide. It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System
| Recall number | Z-1497-2026 |
|---|---|
| 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 | 2026-02-03 |
| Classified | 2026-03-06 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, JP |
| UPC / GTIN / UDI-DI | 05404013801138 |
| Serial numbers | SBF103 |
Product
IBA Proton Therapy System - PROTEUS 235
Reason for recall
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
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-1497-2026. 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.