BEUDAMED
    FDA Recall Terminated

    Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.

    Recall: Z-1548-2009 · Initiated March 6, 2009

    Recall

    Recall Number
    Z-1548-2009
    Event Number
    51485
    Firm
    Gendex Dental Systems
    FEI Number
    3004115000
    Product Code
    MUH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 6, 2009
    Posted
    July 17, 2009
    Terminated
    January 7, 2011
    Address
    901 W Oakton St, Des Plaines, IL, 60018-1843

    Description

    Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.

    Reason

    There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients.

    Action

    Gendex issued an "Urgent Medical Device Report" dated March 6, 2009 to the direct account dealers of the affected device via first class mail. The noticed described the issue and provided a software update directed to fixing the problem. In addition, customers were asked to complete and return an Acknowledgement Form by fax to 1-847-718-0601. Further questions should be directed to the Gendex Technical Support team at 1-888-275-5286.

    Distribution

    Nationwide Distribution.

    Quantity

    1,256 units