Mevion recalls S250 proton radiation treatment systems with a sharp screen edge that could injure service technicians during maintenance. Affected units have specific lot numbers and UDI codes.
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
Mevion is recalling its S250 Proton Radiation Treatment System because a perforated screen inside the water tank has a sharp edge that could cause injury to service technicians. This recall affects specific units with listed lot numbers and unique identifiers.
The perforated screen that separates the water tank has a sharp edge along the top of the heat exchanger. This sharp edge could cause injury to service technicians during routine maintenance or repairs if they come into contact with it.
Healthcare facilities using the Mevion S250 system are most at risk, particularly service technicians who handle the equipment. The recall applies to specific units with documented lot numbers and UDI codes.
Check for lot numbers MEVION S250-0001 through MEVION S250-0008. Also look for unique identifiers (UDIs) with specific codes like (01)00864366000100 and (11)131209.
Identify if your unit has lot numbers MEVION S250-0001 through MEVION S250-0008 or the listed UDI codes.
The recall is due to a perforated screen with a sharp edge that could cause injury to service technicians during maintenance.
Check if your unit has the specific lot numbers or UDI codes listed in the recall notice. If it does, contact Mevion for further instructions.
The recall record does not specify a remedy, so no immediate fix is provided. Affected units should be checked for the listed identifiers.
We’ve drafted a message you can send Mevion to request your refund or repair — edit it as you like.
Subject: Recall Z-2686-2020 — Mevion Mevion Hello, I own a Mevion that is covered by recall Z-2686-2020 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.