Fujifilm Medical Systems U.S.A., Inc. recalls ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-250…

Recall date

July 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0386-2018

FDA classification

Class II

Brand / firm

Fujifilm Medical Systems U.S.A., Inc.

Sold / distributed

US Distribution and Internationally to Mexico.

Why it was recalled

There was a case that the swivel arm went down unintentionally when it was moved up/down.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.