Mevion recalls S250 and S250i proton therapy hand pendants with risk of unintended motion causing patient injury. Affected units have specific serial numbers and UDI codes.
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
Mevion is recalling hand pendants for proton therapy systems that could move unintentionally during treatment, potentially causing injury to patients. This recall affects specific models and serial numbers used in cancer treatment facilities.
The hand pendant controls movement of the therapy couch and nozzle. If it malfunctions, it could cause unintended motion that might lead to patients touching the nozzle or other objects in the treatment room.
Patients receiving proton therapy at facilities using the recalled hand pendants are at risk. Medical staff operating the equipment with these pendants may also be affected.
Check for hand pendants with serial numbers P/N 10263 or P/N 37808. The therapy system UDI codes 00864366000100 and 00864366000124 are also affected.
Look for serial numbers P/N 10263 or P/N 37808 on the hand pendant.
Confirm if your therapy system has the affected UDI codes 00864366000100 or 00864366000124.
The hand pendant could cause unintended motion of the therapy couch and nozzle, potentially leading to patient injury if they come into contact with the nozzle or other objects in the treatment room.
Check for serial numbers P/N 10263 or P/N 37808 on the hand pendant. Also verify if your therapy system has UDI codes 00864366000100 or 00864366000124.
The recall does not require immediate stoppage; however, you should check if your unit is affected and contact your facility for guidance.
We’ve drafted a message you can send Mevion to request your refund or repair — edit it as you like.
Subject: Recall Z-0827-2022 — Mevion Mevion Hello, I own a Mevion that is covered by recall Z-0827-2022 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.
