BEUDAMED
    FDA Recall Terminated

    MammoTest Breast Biopsy System.

    Recall: Z-0379-05 · Initiated July 9, 2004

    Recall

    Recall Number
    Z-0379-05
    Event Number
    29575
    Firm
    Fischer Imaging Corporation
    FEI Number
    1418957
    Product Code
    IZH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 9, 2004
    Posted
    January 5, 2005
    Terminated
    March 13, 2012
    Address
    12300 Grant St, Denver, CO, 80241-3120

    Description

    MammoTest Breast Biopsy System.

    Reason

    X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.

    Action

    Consignees were notified by letter on 7/9/2004.

    Distribution

    Nationwide, including VA facility in AR, military facilities in CA, FL, GA, MD, MO, NC, TX. Foreign distribution to Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Norway, Poland, Portugal, Russia, Saudi Arabia, Spain, Switzerland, The Netherlands, UK.

    Quantity

    860 units