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Fujifilm Medical Systems U.S.A., Inc. recalls FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital
Recalled September 7, 2016 · FDA recall Z-2690-2016 · Fujifilm Medical Systems U.S.A
Hazard
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly. · FDA Class II
Units
2 Units
Sold at
US Distribution to: NC and HI.
Description
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
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.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →