Ion Beam Applications recalls Proteus 235 proton therapy systems due to potential patient misalignment during multi-isocenter treatments. This medical device is used for cancer treatment. Affected units may require correction to ensure safe radiation delivery.
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Ion Beam Applications is recalling its Proteus 235 proton therapy system because it can misalign patients during treatments involving multiple radiation targets. This could lead to improper radiation delivery and potential treatment complications.
The system can misalign patients when using treatment plans with multiple isocenters. This misalignment might cause radiation to be delivered to unintended areas, potentially affecting treatment effectiveness or safety.
Patients receiving proton therapy using the Proteus 235 system are most at risk. Healthcare providers using this device for cancer treatment may also be affected.
The Proteus 235 is a proton therapy system used for cancer treatment. It was sold with specific patent numbers listed in the recall notice.
Verify if your treatment plan uses multiple isocenters, as this may cause patient misalignment.
The recall notice does not specify whether patients currently receiving treatment are affected.
Check the product's model number and verify it matches the Proteus 235 system described in the recall notice.
The recall does not provide specific action steps for affected units beyond checking for misalignment.
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-0938-2018 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-0938-2018 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.
