BEUDAMED
    FDA Recall Terminated

    iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.

    Recall: Z-1487-2014 · Initiated April 3, 2014

    Recall

    Recall Number
    Z-1487-2014
    Event Number
    67959
    Firm
    Boston Scientific Corporation
    FEI Number
    2939204
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 3, 2014
    Posted
    April 22, 2014
    Terminated
    March 18, 2015
    Address
    47215 Lakeview Blvd, Fremont, CA, 94538-6530

    Description

    iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.

    Reason

    Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measurement may display an inaccurate value that is double the actual distance.

    Action

    Boston Scientific sent an Urgent Medical Device Field Correction letter to all affected customers via hand delivery by BSC sales representatives. The letter identifed the affected product, problem and actions to be taken. Customers were asked to immediately post the Field Correction information in a visible location near the system(s) to ensure it is easily accessible to all users of the device. For question contact your local Sales Representative.

    Distribution

    USA Nationwide Distribution in the states of NY, NC, DC, FL, PA

    Quantity

    9 units