Reported Sep 7, 2016 · Terminated
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343
Is this the product you have?
- 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.
- Lot codes and dates
- 26330437 and 17230408
- Amount recalled
- 2 Units
Where it was sold
Why it was recalled
If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
This product could cause temporary or reversible health problems — stop using it.
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