Ion Beam Applications S.A. recalls IBA Proton Therapy System
- Recalling company
- Ion Beam Applications S.A.
- Product
- IBA Proton Therapy System - PROTEUS 235
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 3, 2026
- Reported
- Mar 18, 2026
- Distribution
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
- Status
- Ongoing
- Quantity
- 4 units (1 US, 3 OUS)
- Lot / codes
- PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
- Company location
- Ottignies-Louvain-La-Neuve, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1497-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1497-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.