Mevion recalls S250i and S250 proton radiation systems due to potential couch correction errors after 3D CT scans. Affected units have specific serial numbers and UDI codes.
Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
Mevion is recalling its S250i and S250 proton radiation treatment systems because couch corrections can be partially lost after using a 3D CT scan. This could lead to inaccurate radiation delivery during treatment. The recall affects specific units with known serial numbers and UDI codes.
The couch correction settings can become partially lost after a 3D CT scan if some correction checkboxes were turned off in previous corrections. This might cause inaccurate radiation delivery during treatment sessions.
Patients receiving proton radiation therapy using the affected S250i or S250 systems are most at risk. Healthcare facilities that use these specific units may also be impacted.
Check for serial numbers starting with MEVION S250-0001 to MEVION S250-0008. Also look for UDI codes matching the listed combinations, such as (01)00864366000100 (11)131209.
Look for serial numbers starting with MEVION S250-0001 to MEVION S250-0008 on the device.
Check for UDI codes matching the listed combinations, such as (01)00864366000100 (11)131209.
The recall is due to potential couch correction errors after using a 3D CT scan, which could lead to inaccurate radiation delivery during treatment.
Check for serial numbers starting with MEVION S250-0001 to MEVION S250-0008 or UDI codes matching the listed combinations.
No action is needed if your device does not have the affected serial numbers or UDI codes.
We’ve drafted a message you can send Mevion to request your refund or repair — edit it as you like.
Subject: Recall Z-2406-2020 — Mevion Mevion Hello, I own a Mevion that is covered by recall Z-2406-2020 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.
