BEUDAMED
    FDA Recall Terminated

    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed

    Recall: Z-0473-2015 · Initiated November 9, 2014

    Recall

    Recall Number
    Z-0473-2015
    Event Number
    69793
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 9, 2014
    Posted
    December 1, 2014
    Terminated
    September 14, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed

    Reason

    Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted .

    Action

    Consignees were notified of the Field Safety Notice via certified mail.

    Distribution

    Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam.

    Quantity

    32