Ion Beam Applications recalls Proteus235 Proton Therapy System due to potential incorrect radiation dose delivery. Affected units have specific serial numbers and were sold in US/EU. Contact for remedy.
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Ion Beam Applications is recalling its Proteus23:5 Proton Therapy System because the first layer of radiation treatment fields may receive more radiation than prescribed. This could lead to unintended tissue damage during cancer treatment.
The system's first layer of radiation treatment fields may be irradiated with incorrect scanning magnet settings. This causes the treated area to receive more radiation than prescribed, potentially causing unintended tissue damage.
Patients receiving proton therapy for localized tumors or other conditions are most at risk. Healthcare facilities using the system in the US and EU are affected.
Check for serial numbers: PAT108, PAT112, SAT116 in the US and PAT107 in the EU. The system is used for proton therapy on localized tumors.
Look for serial numbers PAT108, PAT112, SAT116 in the US or PAT107 in the EU on the device.
The first layer of radiation treatment fields may receive more radiation than prescribed due to incorrect scanning magnet settings.
Check for serial numbers: PAT108, PAT112, SAT116 in the US or PAT107 in the EU.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
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-1205-2022 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-1205-2022 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.
