BEUDAMED
    FDA Recall Terminated

    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

    Recall: Z-2135-2015 · Initiated June 22, 2015

    Recall

    Recall Number
    Z-2135-2015
    Event Number
    71654
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 22, 2015
    Posted
    July 20, 2015
    Terminated
    April 14, 2017
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133

    Description

    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

    Reason

    A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.

    Action

    Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.

    Distribution

    Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina

    Quantity

    A total of 4007 devices, all models