BEUDAMED
    FDA Enforcement Class II Terminated

    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.

    Recall: Z-1585-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1585-2015
    Event ID
    70854
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 13, 2015
    Initiation Date
    February 3, 2015
    Classification Date
    May 6, 2015
    Termination Date
    May 20, 2015
    Address
    419 West Ave, N/A, Stamford, CT, 06902-6343, United States

    Description

    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.

    Reason

    User Manual lacks a description for handling some errors even though the system can be recovered from such errors

    Code Info

    Serial Number: 26320119

    Distribution

    Distributed in HI.

    Quantity

    1 unit