BEUDAMED
    FDA Enforcement Class II Terminated

    Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    Recall: Z-2043-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-2043-2015
    Event ID
    71404
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    September 23, 2013
    Classification Date
    July 8, 2015
    Termination Date
    July 9, 2015
    Address
    3721 Valley Centre Dr Ste 500, N/A, San Diego, CA, 92130-3328, United States

    Description

    Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    Reason

    A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.

    Code Info

    s5 Part number 804200-002 and 804200-014; s5x Part number 807300-001; CORE MOBILE Part Number 400-0100.01. All software versions

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Belgium, United Kingdom, Denmark, Netherlands, Sweden, Iceland, France, Saudi Arabia, Australia, Philippines and Thailand.

    Quantity

    227 total units affected by the issue - all models