BEUDAMED
    FDA Recall Terminated

    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    Recall: Z-0437-06 · Initiated December 7, 2005

    Recall

    Recall Number
    Z-0437-06
    Event Number
    34320
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2005
    Posted
    January 24, 2006
    Terminated
    August 1, 2006
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    Reason

    Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.

    Action

    Datascope sent letters to the distributors and end users on 12/7/2005. This communication states that a Datascope Service Representative will conduct and document the corrective action during a visit to the customer.

    Distribution

    The product was distributed to hospitals and clinics nationwide. There is one US Government account, VA Medical Center, Birmingham, AL.

    Quantity

    110 sites