Use cautionMedical device recall · FDA · Published February 3, 2026
IBA Proton Therapy System PROTEUS 235 Recall: Risk of Mistreatment Without Safety Check
IBA recalls PROTEUS 235 proton therapy systems where safety checks may fail if external gating devices are disconnected. Affected units have specific serial numbers. Contact IBA for details.
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.
“IBA Proton Therapy System PROTEUS 235 Recall: Risk of Mistreatment Without Safety Check.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50056-iba-proton-therapy-system-proteus-235-recall-risk-of-mistreatment. Based on FDA recall #Z-1497-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1497-2026%22&limit=1).
The FDA announced on Feb. 3, 2026, that Ion Beam Applications S.A. is recalling its IBA Proton Therapy System - PROTEUS 235 because the Therapy Safety System may fail to interrupt beam delivery if an external gating signal is lost. This defect poses a risk of mistreatment for patients undergoing therapy.
How to tell if you have it
Brand: Ion Beam Applications
Product: IBA Proton Therapy System - PROTEUS 235
Model: PROTEUS 235
UDI-DI: 05404013801138
Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Distribution: Worldwide, including Florida, Italy, and Japan
The hazard
The Universal Beam Triggering Interface is disabled in the Therapy Safety System configuration. Consequently, the system does not interrupt beam delivery if the Healthy Signal from an external gating device is lost, which may lead to a risk of mistreatment when external gating devices are used.
Context
GovInfoNow's records show Ion Beam Applications S.A. has 21 other recalls on record since Oct. 17, 2017. Other recent recalls of similar products include the Elekta MOSAIQ Oncology System Recall (Dec. 10, 2025), the Hitachi Proton Beam Therapy System Recall (Feb. 6, 2026), and the GE Medical Systems Israel SMV BodyTrack Nuclear Medicine Systems Recall (Dec. 10, 2025).
How to tell if you have this one
Check for serial numbers SBF103 (Japan), SBF124 (Europe), SBF133 (US), or SBF140 (Europe) on the PROTEUS 235 system. The product was sold with specific UDI-DI codes.
Brand
Ion Beam Applications
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Safety Settings
Ensure the external gating device is connected and functioning properly before each therapy session.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall addresses a potential risk of incorrect treatment if the safety feature fails during therapy, but it does not indicate immediate danger to users.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1497-2026 (February 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1497-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.