BEUDAMED
    FDA Recall 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 · Initiated May 11, 2012

    Recall

    Recall Number
    Z-1831-2012
    Event Number
    61913
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 11, 2012
    Posted
    June 20, 2012
    Terminated
    October 22, 2012
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    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.

    Action

    Spacelabs Healthcare, Llc sent a "MEDICAL DEVICE CORRECTION" letter dated May 11, 2012 via mailed, return receipt requested, to US customers. The customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. The letter identified the affected product, problem and actions to be taken. Consignees are advised to turn the power off and then on to restore normal functionality. Updated software will be provided upon completion of validation. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 3 for Technical Support.

    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