Ion Beam Applications recalls Proteus 235 software versions before PTS-8.7.2 due to potential patient treatment errors from software conflicts between clinical and test environments.
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
Ion Beam Applications is recalling Proteus 235 software versions older than PTS-8.7.2 because software conflicts between clinical and test environments could lead to patient treatment errors. This affects medical facilities using the system for proton therapy.
The software can start clinical processes while test processes are still running, potentially using test processes without notifying the clinical user. If the software versions differ between clinical and test environments, it could cause patient treatment errors.
Medical facilities using the Proteus 235 system for proton therapy treatments are likely affected. Patients receiving treatments with the recalled software versions are at risk of errors.
Check if your Proteus 235 software version is older than PTS-8.7.2. The recall covers specific patent registrations in the US and EU.
Verify your Proteus 235 software version to see if it's older than PTS-8.7.2.
The recall covers Proteus 235 software versions before PTS-8.7.2.
Different software versions between clinical and test environments could cause patient treatment errors.
The recall record does not specify any remedy.
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-0466-2022 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-0466-2022 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.
