IBA Proton Therapy System PROTEUS 235
IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.
Contact IBA immediately to verify whether your PROTEUS 235 system is affected and obtain a corrected TSS configuration that re-enables the Universal Beam Triggering Interface.
Recall at a glance
- Quantity recalled
- 4 units (1 US, 3 OUS)
Why it was recalled
IBA Proton Therapy System PROTEUS 235 units have a disabled Universal Beam Triggering Interface (UBTI) in the Therapy Safety System (TSS) configuration, which may fail to interrupt beam delivery if an external gating device signal is lost, risking patient mistreatment during therapy.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
IBA Proton Therapy System - PROTEUS 235
- UDI-DI
- 05404013801138
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification