Ion Beam Applications S.A. recalled four PROTEUS 235 proton therapy systems distributed worldwide, including Florida in the United States, and the countries of Italy and Japan. The defect disables the Therapy Safety System's Universal Beam Triggering Interface, so the system may not stop beam delivery if the Healthy Signal from an external gating device is lost. Patients and healthcare providers应该
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ion Beam Applications S.A. or your healthcare provider for instructions. Notification method: Letter
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PROTEUS 235 is a proton therapy system used in cancer treatment. Hospitals and clinics purchase it for precise radiation therapy.
If the therapy safety mechanism does not interrupt beam delivery when gating signals are lost, patients may receive mistreatment.
This recall is not described as part of a broader industry pattern.
Recalled devices require clinicians to halt treatments until guidance is provided.
Recall letter and FDA enforcement page; manufacturer communications
No specific timeline published; follow manufacturer guidance
Document all communications with the manufacturer, hospital administrators, and patients.
Product: PROTEUS 235 proton therapy system. Brand: Ion Beam Applications. Model numbers: PROTEUS 235; UDI-DI 05404013801138. Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU). Sold worldwide. US distribution in Florida, plus Italy and Japan. Recall date: 2026-02-03. Status: ACTIVE. Price: Unknown.
No injuries or incidents have been reported.
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