Ion Beam Applications recalls specific proton therapy systems due to risk of safety parameters being out of tolerance during irradiation. Affected models include PROTEUS 235, PTS-10, PTS-11, and PTS-12 versions. No remedy is specified in the recall notice.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Ion Beam Applications is recalling specific versions of their proton therapy systems (PROTEUS 235, PTS-10, PTS-11, and PTS-12) because safety parameters may go out of tolerance during treatment, potentially allowing irradiation to occur when it should not. This could lead to unintended radiation exposure if the system is used without proper safety checks.
The system may allow irradiation to occur when safety parameters are out of tolerance, meaning radiation could be delivered to patients without proper safety checks. This risk arises from the system's inability to prevent radiation exposure when critical safety thresholds are not maintained.
Medical facilities using the recalled proton therapy systems are most at risk. Patients receiving treatment with these models could face unintended radiation exposure if the safety parameters are not properly monitored.
Check for the model numbers PROTEUS 235, PTS-10, PTS-11, or PTS-12 on the device. Serial numbers include SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, and SBF.135. All configurations of these models are affected.
Identify the model number on the device to see if it matches PROTEUS 235, PTS-10, PTS-11, or PTS-12.
The recall is due to a risk that safety parameters may go out of tolerance during irradiation, potentially allowing radiation exposure to occur when it should not.
The affected models are PROTEUS 235, PTS-10, PTS-11, and PTS-12 versions with specific serial numbers listed in the recall notice.
The recall notice does not specify any remedy or action for affected devices.
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-1603-2024 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-1603-2024 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.
