Ion Beam Applications recalls ProteusPLUS and ProteusONE proton therapy systems due to potential risk of incorrect beam range after resuming treatment pauses. This could lead to unintended radiation delivery to patients.
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Ion Beam Applications is recalling two proton therapy systems (ProteusPLUS and ProteusONE) because they may deliver incorrect radiation doses to patients after resuming treatment sessions. This risk occurs if the operator manually changes the beam range during a treatment pause, which could cause unintended radiation exposure.
The systems may not verify if the beam range has been manually altered during a treatment pause. If an operator changes the range while the treatment is paused, the system could resume with an incorrect beam range, potentially delivering radiation to unintended areas of the body.
Patients receiving proton therapy treatments at facilities using these systems are affected. Medical staff operating the equipment are at the highest risk of causing unintended radiation exposure.
The recalled products are named ProteusPLUS and ProteusONE. They are used for proton beam therapy in medical treatments. The specific model numbers and serial numbers are not clearly stated in the recall notice.
Verify if the system has been used for proton beam therapy treatments.
Reach out to Ion Beam Applications for guidance on system safety and potential remedies.
The systems may not verify if the beam range has been manually altered during a treatment pause, which could lead to incorrect radiation delivery after resuming treatment.
Patients receiving treatments with these systems could be at risk of unintended radiation exposure if the beam range is manually changed during a pause.
The products are named ProteusPLUS and ProteusONE, but specific model numbers and serial numbers are not clearly stated in the recall notice.
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-0747-2022 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-0747-2022 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.
