BEUDAMED
    FDA Recall Terminated

    Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.

    Recall: Z-2193-2011 · Initiated February 6, 2009

    Recall

    Recall Number
    Z-2193-2011
    Event Number
    58421
    Firm
    Digisonics, Inc
    FEI Number
    1626313
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2009
    Posted
    May 13, 2011
    Terminated
    May 31, 2011
    Address
    3701 Kirby Dr, Ste 930, Houston, TX, 77098-3922

    Description

    Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc.

    Reason

    Left ventricle volume was inaccurate when the volumes were measured from images having different scales.

    Action

    The firm, Digisonics, notified consignees/customers via e-mail entitled "Distribution of Notification of Biplane Error" dated February 6, 2009. The email described the product, problem and actions to be taken. The customers were instructed to immediately contact Digisonics if their site calculates biplane volumes-a utility will be provided which will run on their database and identify all studies in which biplane volumes are calculated. The customers were also instructed to share the following important information with all users of DigiView at their site. The email stated -until the software patch has been installed, biplane volumes should be calculated only from pairs of images having the same depth scale. Replacement DigiView/ERS software that prevents further occurrence of this problem will be provided if it appears their site could be impacted. The Distribution of New Software Release was sent on March 6, 2009. If you have any questions, please call Digisonics Customer Support at 800-344-4266

    Distribution

    Worldwide distribution: USA (Nationwide) and countries of: Canada, Lebanon and New Zealand.

    Quantity

    74 units