Ion Beam Applications recalls specific versions of their Proton Therapy System software due to potential safety parameter deactivation during clinical use. Affected units include ProteusPLUS and ProteusONE software versions PTS-8 through PTS-12.
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Ion Beam Applications is recalling specific versions of their Proton Therapy System software (ProteusPLUS and ProteusONE) because safety mechanisms could be deactivated during clinical use. This could lead to unsafe conditions if the system is not properly monitored.
The safety parameters verification mechanisms in the software can be deactivated during clinical operation. This means the system might not properly monitor critical safety functions, potentially leading to unsafe treatment conditions.
Healthcare facilities using the affected software versions are most at risk. Patients receiving proton therapy treatments with these systems may be impacted if the safety mechanisms fail.
Check for software versions PTS-8 through PTS-12 in the ProteusPLUS and ProteusONE systems. Affected units have specific serial numbers listed in the recall notice.
Identify the software version by checking the system's settings or documentation.
Reach out to Ion Beam Applications for guidance on whether your system is affected and next steps.
Software versions PTS-8 through PTS-12 in ProteusPLUS and ProteusONE systems.
Check for the specific serial numbers listed in the recall notice, which include PAT.107 through SAT.140 and other identifiers.
Contact Ion Beam Applications directly for guidance on whether your system is affected and what steps to take.
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-3089-2024 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-3089-2024 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.
