BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

    Recall: Z-1891-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1891-2018
    Event ID
    79715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    March 22, 2018
    Classification Date
    May 17, 2018
    Termination Date
    April 28, 2021
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133, United States

    Description

    Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

    Reason

    The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.

    Code Info

    Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.

    Distribution

    Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.

    Quantity

    8 devices