FDA-Device2018-01-24Class II
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Sold states
US Distribution and Internationally to Mexico.
Affected count
15 US 1 OUS
Manufactured in
419 West Ave, N/A, Stamford, CT, United States
Products
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0386-2018Don't want to check this manually?
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