BEUDAMED
    FDA Enforcement Class II Terminated

    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

    Recall: Z-2345-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2345-2012
    Event ID
    63102
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2012
    Initiation Date
    August 24, 2012
    Classification Date
    September 10, 2012
    Termination Date
    November 25, 2014
    Address
    2870 Kilgore Rd, N/A, Rancho Cordova, CA, 95670-6133, United States

    Description

    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.

    Reason

    The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.

    Code Info

    All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02

    Distribution

    Worldwide Distribution.

    Quantity

    1020 units