IBA recalls PROTEUS 235 proton therapy systems where safety checks may fail if external gating devices are disconnected. Affected units have specific serial numbers. Contact IBA for details.
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.
IBA is recalling PROTEUS 235 proton therapy systems because a safety feature might not stop the beam if an external device loses connection. This could cause incorrect treatment if the system isn't properly monitored.
The system's safety feature might not stop the beam if an external device loses connection. This could lead to incorrect treatment if the system isn't properly monitored during therapy sessions.
Patients receiving proton therapy using the PROTEUS 235 system are most at risk. Healthcare facilities that use this equipment may also be affected.
Check for serial numbers SBF103 (Japan), SBF124 (Europe), SBF133 (US), or SBF140 (Europe) on the PROTEUS 235 system. The product was sold with specific UDI-DI codes.
Ensure the external gating device is connected and functioning properly before each therapy session.
The recall addresses a potential risk of incorrect treatment if the safety feature fails during therapy, but it does not indicate immediate danger to users.
Check for serial numbers SBF103 (Japan), SBF124 (Europe), SBF133 (US), or SBF140 (Europe) on your PROTEUS 235 system.
The recall does not specify a remedy; users should check safety settings and ensure external devices are properly connected.
We’ve drafted a message you can send Ion Beam Applications to request your refund or repair — edit it as you like.
Subject: Recall Z-1497-2026 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-1497-2026 from Ion Beam Applications. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
