Quick Facts at a Glance
- Recall Date
- February 3, 2026
- Hazard Level
- HIGH
- Brand
- Ion Beam Applications
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Ion Beam Applications
- Product type
- Proton Therapy System
- Model numbers
- PROTEUS 235, 05404013801138, SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 3, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ion Beam Applications S.A. or your healthcare provider for instructions. Notification method: Letter
About This Product
PROTEUS 235 is a proton therapy system used in cancer treatment. Hospitals and clinics purchase it for precise radiation therapy.
Why This Is Dangerous
If the therapy safety mechanism does not interrupt beam delivery when gating signals are lost, patients may receive mistreatment.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Recalled devices require clinicians to halt treatments until guidance is provided.
Practical Guidance
How to identify if yours is affected
- Confirm device is PROTEUS 235 with the listed serial numbers
- Review recall letter for instructions
Where to find product info
Recall letter and FDA enforcement page; manufacturer communications
What timeline to expect
No specific timeline published; follow manufacturer guidance
If the manufacturer is unresponsive
- Escalate with hospital risk management
- File a formal complaint with the FDA if device remains in service without action
How to prevent similar issues
- Verify safety features during system configuration
- Confirm gating interfaces are correctly implemented before use in clinical settings.
Documentation advice
Document all communications with the manufacturer, hospital administrators, and patients.
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Product Details
Product: PROTEUS 235 proton therapy system. Brand: Ion Beam Applications. Model numbers: PROTEUS 235; UDI-DI 05404013801138. Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU). Sold worldwide. US distribution in Florida, plus Italy and Japan. Recall date: 2026-02-03. Status: ACTIVE. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4 units recalled worldwide (1 US, 3 outside US)
- Product: PROTEUS 235; UDI-DI 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US),S
- Recall Date: 2026-02-03; Status: ACTIVE; Hazard Level: HIGH
- Remedy: Stop using immediately; follow manufacturer instructions; notification by letter
- Replacement products: Varian ProBeam proton therapy system, Mevion S250 proton therapy system, and I
- No injuries or incidents reported
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Safety Guide
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