openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 4
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.
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 of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Code information
1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.
Distribution pattern
Worldwide Distribution.
device · product 2 of 4
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.
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 of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Code information
2000AWS. Released Software Versions: V5.1, V6.0, V6.1. Not Released Software Versions: V5.0, V5.2, V7.0.
Distribution pattern
Worldwide Distribution.
device · product 3 of 4
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.
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 of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Code information
3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.
Distribution pattern
Worldwide Distribution.
device · product 4 of 4
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 traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
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 of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Code information
363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0.
