BEUDAMED
    FDA Recall Terminated

    Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ

    Recall: Z-0150-2008 · Initiated October 9, 2007

    Recall

    Recall Number
    Z-0150-2008
    Event Number
    45405
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 9, 2007
    Posted
    January 17, 2008
    Terminated
    November 4, 2008
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ

    Reason

    Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia alarms will not be announced.

    Action

    Urgent Product Field Correction notices were sent to hospital administrators on October 9, 2007, by certified mail, return receipt requested. The letter describes the scenario that causes the problem and its remediation It also describes how the software upgrade will fix the problem and alerts hospitals that a Datascope Service Representative will be contacting them to arrange for the upgrade.

    Distribution

    Nationwide

    Quantity

    338 sites