Home / Recalls / Medical Devices
Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD P
Recalled January 24, 2018 · FDA recall Z-0385-2018 · 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
20 US
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 HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). 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 →