BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

    Recall: Z-0858-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0858-2016
    Event ID
    72720
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    November 25, 2015
    Classification Date
    February 23, 2016
    Termination Date
    September 6, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

    Reason

    Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

    Code Info

    Software Versions: B.0.X

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.

    Quantity

    1880 units