MEVION S250 Product Usage: Proton Radiation Therapy — Class II medical device recall Z-0409-2017
Terminated recall by Mevion Medical Systems, Inc., reported 2016-11-23, distributed nationwide. Completing Setup Without Program Move Complete Can Cause An Isocenter Error
| Recall number | Z-0409-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mevion Medical Systems, Inc., Littleton, MA, United States |
| Recall initiated | 2016-10-31 |
| Classified | 2016-11-14 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Serial numbers | S250-0001 |
Product
MEVION S250 Product Usage: Proton Radiation Therapy
Reason for recall
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0409-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.