BEUDAMED
    FDA Recall Terminated

    Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.

    Recall: Z-1233-2009 · Initiated January 23, 2009

    Recall

    Recall Number
    Z-1233-2009
    Event Number
    51494
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 23, 2009
    Posted
    May 7, 2009
    Terminated
    March 19, 2013
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.

    Reason

    Image may appear dark, requiring repeat image acquisition.

    Action

    A Customer Safety Advisory Notice dated December 16, 2008 was issued to affected customers via Update Instructions SP040/08/S. The letter described the potential issue and provided instructions to avoid its occurrence. A software update to correct the issue is currently being developed and will be installed on affected systems when it becomes available.

    Distribution

    Nationwide Distribution.

    Quantity

    497 units