BEUDAMED
    FDA Enforcement Class II Terminated

    Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.

    Recall: Z-1156-2014 · Reported March 19, 2014

    Enforcement

    Recall Number
    Z-1156-2014
    Event ID
    67495
    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
    March 19, 2014
    Initiation Date
    January 8, 2014
    Classification Date
    March 7, 2014
    Termination Date
    January 21, 2015
    Address
    800 MacArthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.

    Reason

    Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.

    Code Info

    p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX

    Distribution

    Worldwide Distribution - USA Nationwide Distribution

    Quantity

    732 units in the US