BEUDAMED
    FDA Enforcement Class II 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 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1575-2016
    Event ID
    73693
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    March 9, 2016
    Classification Date
    April 27, 2016
    Termination Date
    April 19, 2018
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    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.

    Code Info

    Panorama Central Station's CPU Unit, Tower (p/n 0998-00-0709-01) Panorama Central Station's CPU Unit, 2U case (p/n 0998-00-0708-01) Panorama Centrall Station's eGateway Tower (p/n 0998-00-0709-03) Panorama Central Station's eGateway 2U case (p/n 0998-00-0708-03)

    Distribution

    Nationwide Distribution

    Quantity

    1447 units US, 45 units OUS