BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0386-2018 · Initiated July 14, 2017

    Recall

    Recall Number
    Z-0386-2018
    Event Number
    78891
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 14, 2017
    Posted
    January 17, 2018
    Terminated
    July 20, 2018
    Address
    419 West Ave, Stamford, CT, 06902-6343

    Description

    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.

    Reason

    There was a case that the swivel arm went down unintentionally when it was moved up/down.

    Action

    FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers. PLEASE READ AND FOLLOW THE INSTRUCTIONS Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section. We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us. If you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.

    Distribution

    US Distribution and Internationally to Mexico.

    Quantity

    15 US 1 OUS