IBA Proton Therapy System - PROTEUS 235
- Recall Initiated
- February 3, 2026
- Posted
- March 6, 2026
- Recall Number
- Z-1497-2026
- Quantity
- 4 units (1 US, 3 OUS)
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Lot / Code Info
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
Root Cause
Software design
Action Taken
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.