Fujifilm Medical Systems U.S.A., Inc.: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set

Agency Publication Date: February 20, 2018

Affected Products

Product: Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.

Product: Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-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.

2000AWS. Released Software Versions: V5.1, V6.0, V6.1. Not Released Software Versions: V5.0, V5.2, V7.0.

Product: ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.

Product: Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as tr

363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79078

Status: Resolved

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

Manufactured In: United States

Units Affected: 4 products (71 units (68 units Domestic. 3 units Foreign) in total)

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Sources: FDA iRES · Raw API Response

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Affected Products

1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.

2000AWS. Released Software Versions: V5.1, V6.0, V6.1. Not Released Software Versions: V5.0, V5.2, V7.0.

3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.

363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0.