BEUDAMED
    FDA Recall Terminated

    Philips Healthcare IntelliVue Info Center iX, A.0 866023

    Recall: Z-0856-2016 · Initiated November 25, 2015

    Recall

    Recall Number
    Z-0856-2016
    Event Number
    72720
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    November 25, 2015
    Posted
    February 23, 2016
    Terminated
    September 6, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Healthcare IntelliVue Info Center iX, A.0 866023

    Reason

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

    Action

    Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.

    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

    5671 units