FDA Enforcement
Class II
Terminated
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.
Recall: Z-2690-2016
·
Reported September 7, 2016
Enforcement
- Recall Number
- Z-2690-2016
- Event ID
- 74525
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 7, 2016
- Initiation Date
- June 9, 2016
- Classification Date
- August 30, 2016
- Termination Date
- September 19, 2016
- Address
- 419 West Ave, N/A, Stamford, CT, 06902-6343, United States
Description
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.
Code Info
26330437 and 17230408
Distribution
US Distribution to: NC and HI.
Quantity
2 Units