BEUDAMED
    FDA Enforcement Class II 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 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0473-2015
    Event ID
    69793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    November 9, 2014
    Classification Date
    November 26, 2014
    Termination Date
    September 14, 2015
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    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 .

    Code Info

    IntelliSpace Portal DX/HX/EX: 96027,96029,96025,96030,96031,85479,79935, 98087,85175,96024,106013,450003, 950002, 950003,35009,35030,870056, 550012, 85081, 97069, 45001985333, 35036, and 85382. IntelliSpace Portal DX/HX/EX Upgrade: 950100, 55003, and 81178. IntelliSpace Portal DX/HX/EX Demo: 85451 and 87290. IntelliSpace Portal IX: 50306, 40219, and 40368. 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

    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