BEUDAMED
    FDA Recall Terminated

    Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.

    Recall: Z-1104-05 · Initiated June 16, 2005

    Recall

    Recall Number
    Z-1104-05
    Event Number
    32617
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    DRT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2005
    Posted
    August 6, 2005
    Terminated
    October 5, 2005
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.

    Reason

    Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.

    Action

    The firm sent a field correction communications to all customers via certified mail on 6/10/2005. A Datascope Service Representative will conduct and document this corrective action during a visit to the customer.

    Distribution

    There were 68 domestic customers nationwide and 2 international customers in Belgium and Italy.

    Quantity

    70 units