Device 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.
Z-2690-2016
Product summary
- Event
- Event 74525
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 Units
- Official record key
device-enforcement:Z-2690-2016
Official wording
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.
Code information: 26330437 and 17230408
Distribution pattern: US Distribution to: NC and HI.
Derived failure modes
-
Unknown
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.