BEUDAMED
    FDA Recall Terminated

    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.

    Recall: Z-1575-2016 · Initiated March 9, 2016

    Recall

    Recall Number
    Z-1575-2016
    Event Number
    73693
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 9, 2016
    Terminated
    April 19, 2018
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.

    Reason

    Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.

    Action

    Mindray DS USA Inc. issued a Medical Device Service Notice dated March 9, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers requiring technical assistance were instructed to contact Mindray's Technical Support team at 1-800-288-2121. Mindray will address the systems response to DST in a future software update which will be provided to the customer at no cost.

    Distribution

    Nationwide Distribution

    Quantity

    1447 units US, 45 units OUS