Mevion recalls S250i and S250 proton radiation treatment systems due to risk of missing treatment beam information during patient therapy, potentially causing harm.
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Mevion is recalling its S250i and S250 proton radiation treatment systems because the treatment console may show disappearing beam information while delivering radiation, which could harm patients. This issue affects specific units with serial numbers listed in the recall notice.
The treatment console screen may lose critical beam information while radiation delivery continues, potentially causing incorrect treatment doses or harm to patients. This happens due to a software or hardware issue that fails to maintain proper display during therapy sessions.
Healthcare facilities using the Mevion S250i or S250 systems with the listed serial numbers are affected. Patients receiving proton radiation treatment with these systems are at risk if the beam information disappears during treatment.
Check for serial numbers starting with MEVION S250-0001 through MEVION S250-0008. The unique device identifiers (UDIs) listed in the recall include specific date codes that match the affected units.
Verify your system's serial number against the list of affected units: MEVION S250-0001 through MEVION S250-0008.
The treatment console may show disappearing beam information during radiation delivery, which could lead to patient harm if the system does not properly display critical treatment data.
Check your serial number against the list: MEVION S250-0001 through MEVION S250-0008. Affected units also have specific unique device identifiers (UDIs) with matching date codes.
The recall does not specify a remedy, so contact Mevion Medical Systems directly for guidance on next steps.
We’ve drafted a message you can send Mevion to request your refund or repair — edit it as you like.
Subject: Recall Z-0485-2021 — Mevion Mevion Hello, I own a Mevion that is covered by recall Z-0485-2021 from Mevion. 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.
