FDAFebruary 3, 2015device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

User Manual lacks a description for handling some errors even though the system can be recovered from such errors

What to do

FDA enforcement status: Terminated

Brands named

fujifilm medical systems ufujifilmfujifilm medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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