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-

Recalled January 24, 2018 · FDA recall Z-0386-2018 · Fujifilm Medical Systems U.S.A

Hazard

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

Units

15 US 1 OUS

Sold at

US Distribution and Internationally to Mexico.

Description

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

Product

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.

Manufacturer(s)

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →