BEUDAMED
    FDA Enforcement Class II Terminated

    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.

    Recall: Z-1783-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1783-2014
    Event ID
    64507
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    March 5, 2013
    Classification Date
    June 11, 2014
    Termination Date
    May 17, 2017
    Address
    3000 Minuteman Road, N/A, Andover, MA, 01810, United States

    Description

    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.

    Reason

    If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.

    Code Info

    All iX versions with A.01 software

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Canada.

    Quantity

    899