Mevion S250i Recall: Risk of Treatment Interruption Due to Interlock Trip

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Recalling firmMevion Medical Systems, Inc.300 Foster St · Littleton, MA 01460-2017

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Status
Ensure the dDose1 interlock system is functioning properly before each treatment session.

✎ GovInfoNow

Questions people ask

Is this recall affecting my treatment?

The recall may cause treatment interruptions if the dDose1 interlock trips. Contact Mevion directly for specific guidance.

How do I know if my device is affected?

Check for the serial number S250i-0007 on your Mevion S250i device. This specific serial number is affected.

What should I do if my device trips the interlock?

The recall does not specify a remedy. Contact Mevion for advice on handling interlock trips during treatment.

Take action

Contact Mevion

We’ve drafted a message you can send Mevion to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0705-2019 — Mevion Mevion

Hello,

I own a Mevion that is covered by recall Z-0705-2019 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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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.

Mevion Medical Systems, Inc. recalls MEVION S250i

Use caution until it’s fixed