Mevion S250i Recall: Risk of Treatment Interruption Due to Interlock Trip
Mevion recalls S250i radiation therapy devices that may cause treatment interruptions if dDose1 interlock trips. Affected units have specific serial numbers and were sold in the U.S. Learn what to do.
Use caution until it’s fixed
Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
Contact the company
What happened, in plain English
Mevion is recalling its S250i radiation therapy devices because a safety interlock system can trip during treatment, potentially interrupting therapy. This could affect patients receiving radiation treatment. Read more at govinfonow.com/recall/69713-mevion-s250i-recall-risk-of-treatment-interruption-due-to-interlock.
Source Summary by GovInfoNow · govinfonow.com/recall/69713-mevion-s250i-recall-risk-of-treatment-interruption-due-to-interlock · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0705-2019
Cite this page
“Mevion S250i Recall: Risk of Treatment Interruption Due to Interlock Trip.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69713-mevion-s250i-recall-risk-of-treatment-interruption-due-to-interlock. Based on FDA recall #Z-0705-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0705-2019%22&limit=1).
Why it’s dangerous
The dDose1 interlock system is designed to stop treatment if a safety issue occurs. If this system trips unexpectedly, it can interrupt radiation therapy, which may delay treatment for patients.
Who’s affected
Patients using the Mevion S250i radiation therapy device for cancer treatment are most at risk. The recall applies to specific units with the serial number S250i-0007.
How to tell if you have this one
Check for the serial number S250i-0007 on your device. The Mevion S250i was sold in the U.S. with this specific serial number.
- Brand
Mevion- Product
MEVION S250i- Category
Medical device
What to do — step by step
Check Device Status
Ensure the dDose1 interlock system is functioning properly before each treatment session.
Where it went and when
Where it was distributed
Distributed in D.C..
FDA distribution: “DC” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: District of Columbia.
Recall timeline
FDA terminated this recall 18 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.
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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-0705-2019 (October 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0705-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.