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Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screen
Recalled May 13, 2015 · FDA recall Z-1585-2015 · Fujifilm Medical Systems U.S.A
Hazard
User Manual lacks a description for handling some errors even though the system can be recovered from such errors · FDA Class II
Units
1 unit
Sold at
Distributed in HI.
Description
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Product
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →