The Recall Desk

FDA (Devices) recall action 79078

Fujifilm Medical Systems U.S.A., Inc. recalled 4 products on 2018-02-28

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-02-28
Critical
0
Units
—

Why these products were recalled

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, i…

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • ModerateFDA (Devices)··2018-02-28

    Fujifilm Aspire HD Mammography System Recalled for Image ID Error

    Fujifilm is recalling Aspire HD mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    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
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  • ModerateFDA (Devices)··2018-02-28

    Fujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors

    Fujifilm is recalling ASPIRE Cristalle mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images in hospital systems.

    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 in
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  • ModerateFDA (Devices)··2018-02-28

    Fujifilm Recalls Digital Mammography Systems Due to Image ID Error

    Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.

    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
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  • HighFDA (Devices)··2018-02-28

    Fujifilm Recalls Mammography Software Due to Potential Image Overwrite Error

    Fujifilm is recalling 71 units of the Fuji Computed Radiography Mammography Suite because a software error may cause new images to overwrite previous ones in the hospital system.

    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)
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