BEUDAMED
    FDA Recall 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 · Initiated May 16, 2013

    Recall

    Recall Number
    Z-1587-2013
    Event Number
    65371
    Firm
    U-systems Inc
    FEI Number
    3003248267
    Product Code
    PAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 16, 2013
    Posted
    June 24, 2013
    Terminated
    November 4, 2013
    Address
    447 Indio Way, Sunnyvale, CA, 94085-4203

    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].

    Action

    On 6/5/13, an "URGENT MEDICAL DEVICE CORRECTION" letter was distributed to all affected users, with a description of the problem and user corrective action steps. One consignee received an Urgent Notice to Customer - Medical Device Correction letter on 5/16/13. Contact the firm at 408-328-7925 for questions regarding this notice.

    Distribution

    Distributed in California and Illinois.

    Quantity

    3 units