BEUDAMED
    FDA Enforcement Class II Terminated

    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.

    Recall: Z-1831-2012 · Reported June 27, 2012

    Enforcement

    Recall Number
    Z-1831-2012
    Event ID
    61913
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2012
    Initiation Date
    May 11, 2012
    Classification Date
    June 20, 2012
    Termination Date
    October 22, 2012
    Address
    5150 220th Ave Se, N/A, Issaquah, WA, 98029-6834, United States

    Description

    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.

    Reason

    The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker.

    Code Info

    Version 1.6.0.

    Distribution

    Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND, ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.

    Quantity

    114