BEUDAMED
    FDA Recall 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 · Initiated September 23, 2013

    Recall

    Recall Number
    Z-2043-2015
    Event Number
    71404
    Firm
    Volcano Corp
    FEI Number
    3008363989
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 23, 2013
    Posted
    July 8, 2015
    Terminated
    July 9, 2015
    Address
    3721 Valley Centre Dr, Ste 500, San Diego, CA, 92130-3328

    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.

    Action

    Volcano and Philips sent an Advisory Notice letter dated September 23, 2013 to all impacted customers. The letter identified the affected product, problem and actions to be taken. For question contact your Volcano and Philips representative.

    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