MEVION S250 Product Usage: Proton Radiation Therapy System — Class II medical device recall Z-0411-2017
Terminated recall by Mevion Medical Systems, Inc., reported 2016-11-23, distributed nationwide. Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their tru
| Recall number | Z-0411-2017 |
|---|---|
| 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 | 2016-10-20 |
| Classified | 2016-11-14 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Reason classes | software |
| Serial numbers | S250-0001 |
Product
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason for recall
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
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-0411-2017. 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.