FDA Class II Recall: Ion Beam Applications PROTEUS 235
Summary
The FDA has issued a Class II recall for the Ion Beam Applications PROTEUS 235 due to a safety system issue where the Universal Beam Triggering Interface (UBTI) can be disabled, potentially leading to mistreatment if the external gating device signal is lost. The recall affects worldwide distribution, including nationwide distribution in Florida, Italy, and Japan.
What changed
The FDA has classified a Class II recall for Ion Beam Applications' PROTEUS 235 device, identified under recall number Z-1497-2026, with an effective date of March 18, 2026. The issue stems from a safety system configuration where the Universal Beam Triggering Interface (UBTI) is disabled. This prevents the Therapy Safety System (TSS) from interrupting beam delivery if the signal from an external gating device is lost, posing a risk of mistreatment to patients.
Healthcare providers and facilities that have the PROTEUS 235 device should immediately review their safety system configurations and ensure the UBTI is properly enabled and functioning. Failure to address this issue could result in patient mistreatment during therapy. The recall affects distribution in the US (Florida), Italy, and Japan. Compliance officers should verify their institution's adherence to safety protocols related to this device and consult Ion Beam Applications for specific remediation steps.
What to do next
- Verify PROTEUS 235 safety system configuration
- Ensure UBTI is enabled and functioning
- Consult Ion Beam Applications for remediation steps
Archived snapshot
Mar 29, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Ion Beam Applications S.A.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1497-2026 · 20260318 · Ongoing
Product
IBA Proton Therapy System - PROTEUS 235
Reason for Recall
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 mistreatmen...
Distribution
Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Source: openFDA Enforcement API
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