BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1487-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1487-2014
    Event ID
    67959
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    April 3, 2014
    Classification Date
    April 22, 2014
    Termination Date
    March 18, 2015
    Address
    47215 Lakeview Blvd, N/A, Fremont, CA, 94538-6530, United States

    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.

    Code Info

    Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software.

    Distribution

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

    Quantity

    9 units