FDA Medical devices recall ·
IBA Proton Therapy System - PROTEUS 235 recall
- Recall number
- Z-1497-2026
- Date
- (initiated February 3, 2026)
- Company / brand
- Ion Beam Applications S.A.
Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, N/A, Belgium - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 units (1 US, 3 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IBA Proton Therapy System - PROTEUS 235
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Distribution
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
States: Florida
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1497-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.