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FDA-Device2026-03-18Class IIPROCESSING DEFECT

IBA PROTEUS 235 proton therapy system recalled for disabled safety beam interruption

Ion Beam Applications
OTHERNationwide distribution

Contact IBA if you operate PROTEUS 235 proton system

A safety feature in the IBA PROTEUS 235 proton therapy system can become disabled, preventing automatic beam shutdown if an external gating device loses signal. This affects only 4 specific units worldwide and may result in incorrect radiation delivery during treatment.

  • If your facility operates serial number SBF103, SBF124, SBF133, or SBF140, contact IBA immediately
  • Do not use external gating devices on affected units until IBA confirms the safety fix
  • Verify your system serial number and contact IBA for required configuration correction
Hazard

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.

Sold states
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Affected count
4 units (1 US, 3 OUS)
Manufactured in
Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, Belgium
Products
IBA Proton Therapy System - PROTEUS 235

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2026

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