BEUDAMED
    FDA Recall Terminated

    SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery.

    Recall: Z-0713-06 · Initiated October 26, 2005

    Recall

    Recall Number
    Z-0713-06
    Event Number
    34808
    Firm
    Sonosite, Inc.
    FEI Number
    3002087856
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 26, 2005
    Posted
    April 6, 2006
    Terminated
    April 10, 2006
    Address
    21919 30th Dr Se, Bothell, WA, 98021-3904

    Description

    SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery.

    Reason

    When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Underestimates percentage of stenosis, false negative result.

    Action

    On October 26, 2005, the company sent their customers a User Guide Addendum that told customers how to verify that the image calibration data was correct.

    Distribution

    Nationwide, Kuwait, Mexico, South Africa, Chile, Spain, Japan, Puerto Rico, Australia. A list of 155 cases in which the software was sent out lists medical facilities, physicans, and SonoSite Distributors.

    Quantity

    155 units of the SonoCalc product to about 80 customers/distributors