Recall Z-1497-2026 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235
| Date | Mar 6, 2026 (initiated Feb 3, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 4 units (1 US, 3 OUS) |
| Distribution | Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., Aug 17, 2017 |