BEUDAMED
    FDA Recall Terminated

    Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240. DigiView is a digital image management and reporting system with an associated clinical database. It provides capture, review, and storage of images together with report creation and data basing.

    Recall: Z-2180-2011 · Initiated January 20, 2009

    Recall

    Recall Number
    Z-2180-2011
    Event Number
    58395
    Firm
    Digisonics, Inc
    FEI Number
    1626313
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 20, 2009
    Posted
    May 10, 2011
    Terminated
    May 31, 2011
    Address
    3701 Kirby Dr, Ste 930, Houston, TX, 77098-3922

    Description

    Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240. DigiView is a digital image management and reporting system with an associated clinical database. It provides capture, review, and storage of images together with report creation and data basing.

    Reason

    Data from one patient's study had the potential for being put into another patient's report.

    Action

    Digisonics notified end users via e-mail January 20, 2009 and January 21, 2009, that Data from one patient's study was being put into another patient's report. The problem occurred when a System bug was found in DigiView Release 3.6.4.4, and higher versions in which under certain circumstances (specific workflow) a failure to switch to a patient's images occurs. Two software patch versions will be made available to sites on or after February 5, 2009, to correct the reported problem. If you have any further questions, please contact Digisonics Customer Support at (800 ) 940-3240.

    Distribution

    Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN, SC, ID, MN, AR, OK, IL, CT, and countries of Canada, Lebanon, and New Zealand.

    Quantity

    70 units