BEUDAMED
    FDA Recall 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 · Initiated January 8, 2014

    Recall

    Recall Number
    Z-1156-2014
    Event Number
    67495
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 8, 2014
    Posted
    March 7, 2014
    Terminated
    January 21, 2015
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    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 Mindrays 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.

    Action

    Mindray DS USA Inc. sent an Urgent Corrective Action letter dated January 8, 2014 via certified mail to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact Mindray Service Representative, at 1-800-288-2121 (Monday Friday 8:30 am-5:30 pm), to arrange for the software update of the Panorama System(s) in their facility. This work will be performed at no cost.

    Distribution

    Worldwide Distribution - USA Nationwide Distribution

    Quantity

    732 units in the US