MEVION S250 Product Usage: Proton Radiation Therapy System — Class II medical device recall Z-0410-2017
Terminated recall by Mevion Medical Systems, Inc., reported 2016-11-23, distributed nationwide. Recovery of Incorrect Isocenter -operational change
| Recall number | Z-0410-2017 |
|---|---|
| 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 | 2016-10-21 |
| Classified | 2016-11-14 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Serial numbers | S250-0001 |
Product
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason for recall
Recovery of Incorrect Isocenter -operational change
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-0410-2017. 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.