Fujifilm Medical Systems U.S.A., Inc.: There was a case that the swivel arm went down unintentionally when it was moved up/down.

Agency Publication Date: January 17, 2018

Affected Products

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 m

FDR MS-2500 made in Japan : S/N- 16640001 or later FDR MS-2500 made in China : S/N- 26860001 or later FDR MS-2000 made in Japan : S/N- 16650001 or later FDR MS-2000 made in China : S/N- 26870001 or later

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.

FDR MS-3500 : S/N- 76221095 or earlier

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78891

Status: Resolved

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

Manufactured In: United States

Units Affected: 2 products (20 US; 15 US 1 OUS)

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Sources: FDA iRES · Raw API Response

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Affected Products

FDR MS-3500 : S/N- 76221095 or earlier