BEUDAMED
    FDA Enforcement Class II Terminated

    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

    Recall: Z-1587-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1587-2013
    Event ID
    65371
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    U-systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 16, 2013
    Classification Date
    June 24, 2013
    Termination Date
    November 4, 2013
    Address
    447 Indio Way, Sunnyvale, CA, 94085-4203, United States

    Description

    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

    Reason

    Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].

    Code Info

    Serial numbers: H1280099, H1180094, B1380105

    Distribution

    Distributed in California and Illinois.

    Quantity

    3 units