IBA Proton Therapy System - PROTEUS 235 recallZ-1497-2026 · Ion Beam Applications S.A. · initiated Feb 3, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ion Beam Applications S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
On February 3, 2026 Urgent Medical Device Correction letters were sent to customers. Letter provides awareness of the Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. On-site modification of the devices will be performed by IBA with a TSS Configuration update. The update will be deployed at the impacted sites by June 2026.
Recall details
- Recall number
- Z-1497-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 3, 2026
- Posted by the FDA
- Mar 6, 2026
- Recalling firm
- Ion Beam Applications S.A.
- Quantity
- 4 units (1 US, 3 OUS)
- Product code
- LHN
- FDA submissions
- K163500
- Distribution
- Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Product description
IBA Proton Therapy System - PROTEUS 235
Code information (models, lots, serial numbers)
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IBA Proton Therapy System – Proteus 235 Proteus PLUS/Proteus ONEIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical8 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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