FDA recall, , Moderate risk
IBA Proton Therapy System - PROTEUS 235
The IBA Proton Therapy System - PROTEUS 235 has a disabled beam triggering interface, which may lead to mistreatment.
Summary by Recall Canary from the FDA notice
What happened
Ion Beam Applications S.A. of Ottignies-Louvain-La-Neuve, Belgium, recalled the IBA Proton Therapy System - PROTEUS 235 because the 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, which may lead to a risk of mistreatment when external gating devices are used.
The recall began on February 3, 2026, and was added to the FDA's Enforcement Report on March 6, 2026. The product was distributed worldwide, with distribution in the state of Florida and in the countries of Italy and Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
IBA Proton Therapy System - PROTEUS 235
- UDI-DI
- 05404013801138
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the state of Florida and the countries of Italy and Japan.
- Company
- Ion Beam Applications S.A.Ottignies-Louvain-La-Neuve, Belgium
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98364
- Recall number
- Z-1497-2026
- Quantity recalled
- 4 units (1 US, 3 OUS)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
