MEVION S250 — Class II medical device recall Z-0588-2015
Terminated recall by Mevion Medical Systems, Inc., reported 2014-12-17. Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionizat
| Recall number | Z-0588-2015 |
|---|---|
| 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 | 2014-11-10 |
| Classified | 2014-12-11 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-03-18 |
| Quantity | 1 |
| Reason classes | device malfunction, software |
| Serial numbers | S250-0001 |
Product
MEVION S250, used for proton radiation therapy.
Reason for recall
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
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-0588-2015. 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.