FUJIFILM Digital Mammography System Aspire HD — Class II medical device recall Z-2690-2016
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2016-09-07, distributed in HI, NC. If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system f
| Recall number | Z-2690-2016 |
|---|---|
| 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 | 2016-06-09 |
| Classified | 2016-08-30 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2016-09-19 |
| Distributed | HI, NC |
| Quantity | 2 units |
Product
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Reason for recall
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
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-2690-2016. 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.