BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0661-2018 · Initiated August 4, 2017

    Recall

    Recall Number
    Z-0661-2018
    Event Number
    79078
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 4, 2017
    Terminated
    April 1, 2019
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    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.

    Reason

    FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.

    Action

    The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures.. If you have any questions about this matter, call Recall contact (203) 276-3445 or email: [email protected].

    Distribution

    Worldwide Distribution.

    Quantity

    71 units (68 units Domestic. 3 units Foreign) in total