United StatesThe IBA Proton Therapy System — PROTEUS 235 (UDI‑DI 05404013801138) with serial numbers SBF103, SBF124, SBF133, and SBF140, sold worldwide including the U.S. (Florida), Italy and Japan, is being recalled. The Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration so the TSS does not interrupt beam delivery if the Healthy Signal from an external gating device is lost, which may lead to a risk of mistreatment when external gating devices are used.
What's being recalled
IBA Proton Therapy System - PROTEUS 235
Recalling firm: Ion Beam Applications S.A., Ottignies-Louvain-La-Neuve, N/A, Belgium.
How to identify it
PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)