Ion Beam Applications recalls Proteus 235 proton therapy systems due to misleading disconnect messages that may cause incorrect patient treatment. Affected units were sold with specific patents and software versions.
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Ion Beam Applications is recalling its Proteus 235 proton therapy systems because software messages can mislead users about system disconnections, potentially causing incorrect patient treatments. This recall affects medical devices used for targeted radiation therapy.
The system shows a popup message when the Oncology Information System appears disconnected. This message can mislead users into thinking the system is disconnected when it isn't, potentially causing incorrect patient treatments.
Healthcare providers using the Proteus 235 proton therapy system for cancer treatment are most at risk. Patients receiving radiation therapy with this device may be affected if the system displays misleading disconnect messages.
Check for the Proteus 235 proton therapy system with the specific software versions mentioned in the recall notice. The device is used for treating localized tumors and other radiation-sensitive conditions.
Verify if the system displays misleading disconnect messages that could cause incorrect patient treatments.
The Proteus 235 is a proton therapy system designed to treat patients with localized tumors and other conditions using radiation.
The system may display misleading disconnect messages that could cause incorrect patient treatments if users misinterpret the system status.
The recall record does not specify a remedy or fix for this issue.
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-2434-2021 — Ion Beam Applications Ion Beam Applications Hello, I own a Ion Beam Applications that is covered by recall Z-2434-2021 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.