Z-2690-2016 Class II Terminated
FDA device recall Z-2690-2016 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Jun 9, 2016 and is designated Class II. 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. The recall status is terminated (terminated Sep 19, 2016). Affected quantity: 2 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2016
- Initiation Date
- Jun 9, 2016
- Termination Date
- Sep 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 Units
Product 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 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.
Distribution Pattern
US Distribution to: NC and HI.
Code Information
26330437 and 17230408
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2690-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026