FDA Device recall Z-2690-2016
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, A…
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, A… by Fujifilm Medical Systems U, citing if an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2690-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-09 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | HI, NC |
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
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
Identifiers
| code_info | 26330437 and 17230408 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2690-2016%22
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