IBA PROTEUS 235 proton therapy system recalled for disabled safety beam interruption
What this means
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
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.