BEUDAMED
    FDA Recall Terminated

    Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station.

    Recall: Z-1401-2009 · Initiated April 10, 2009

    Recall

    Recall Number
    Z-1401-2009
    Event Number
    51863
    Firm
    Mindray DS USA, Inc., dba Datascope Patient Monitoring
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 10, 2009
    Posted
    May 27, 2009
    Terminated
    August 3, 2010
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430

    Description

    Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station.

    Reason

    Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.

    Action

    Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.

    Distribution

    Worldwide Distribution -- USA and Australia.

    Quantity

    294 sites