Aspire HD — Class II medical device recall Z-1585-2015
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2015-05-13. User Manual lacks a description for handling some errors even though the system can be recovered from such err
| Recall number | Z-1585-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, United States |
| Recall initiated | 2015-02-03 |
| Classified | 2015-05-06 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-05-20 |
| Quantity | 1 units |
| Serial numbers | 26320119 |
| Model numbers | MS-1000 |
Product
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Reason for recall
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
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-1585-2015. 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.