BEUDAMED
    FDA Recall Terminated

    Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.

    Recall: Z-1675-2015 · Initiated March 12, 2015

    Recall

    Recall Number
    Z-1675-2015
    Event Number
    70959
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 12, 2015
    Posted
    May 26, 2015
    Terminated
    March 28, 2017
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.

    Reason

    Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and Panorama will not be displayed on the Panorama following a restart of either system (due to communication loss, restart, etc.).

    Action

    Mindray sent a Corrective Action letter dated March 12, 2015 to their affected customer via FedEx. The letter identified the affected product, problem and actions to be taken. For questions call 201-995-8407.

    Distribution

    Worldwide Distribution - US Nationwide in the state of TX.

    Quantity

    4 units