BEUDAMED
    FDA Recall Terminated

    Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810

    Recall: Z-1546-2008 · Initiated February 28, 2008

    Recall

    Recall Number
    Z-1546-2008
    Event Number
    47386
    Firm
    Lorad, A Hologic, Inc.
    FEI Number
    1220984
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 28, 2008
    Posted
    May 28, 2008
    Terminated
    February 3, 2009
    Address
    36 Apple Ridge Rd, Danbury, CT, 06810-7301

    Description

    Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810

    Reason

    Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.

    Action

    Consignees were notified by an Urgent Recall Notice sent on 3/21/08. The letter informed users that representatives were dispatched to all locations and they have corrected the magnification factor problem. The letter instructed users to re-evaluate any cases read using CAD from the period of installation until the date of system correction. The letter also instructed users that only images read with CAD markers are affected. The letter requests users to return a confirmation of notification. For additional information, contact 1-877-371-4372.

    Distribution

    Worldwide Distribution including USA and countries of Canada and the Republic of Korea.

    Quantity

    73 units