Mevion S250i and S250 Proton Radiation Systems: Couch Correction Errors
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.
Lower-risk recall
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
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/65148-mevion-s250i-and-s250-proton-radiation-systems-couch-correction-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/65148-mevion-s250i-and-s250-proton-radiation-systems-couch-correction-errors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2406-2020
Cite this page
“Mevion S250i and S250 Proton Radiation Systems: Couch Correction Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65148-mevion-s250i-and-s250-proton-radiation-systems-couch-correction-errors. Based on FDA recall #Z-2406-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Mevion- Product
MEVION S250i, MEVION S250; Proton Radiation Treatment System- Category
Medical device
What to do — step by step
Check Serial Numbers
Look for serial numbers starting with MEVION S250-0001 to MEVION S250-0008 on the device.
Verify UDI Codes
Check for UDI codes matching the listed combinations, such as (01)00864366000100 (11)131209.
Where it went and when
Where it was distributed
Distributed in 5 states and D.C., and outside the U.S.
FDA distribution: “Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: District of Columbia, Florida, Missouri, New Jersey, Ohio, Oklahoma.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-2406-2020 (May 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2406-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.