FDA-Device2015-05-13Class II
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Fujifilm Medical Systems U.S.A., Inc.
Hazard
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Sold states
Distributed in HI.
Affected count
1 unit
Manufactured in
419 West Ave, N/A, Stamford, CT, United States
Products
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2015Don't want to check this manually?
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