BEUDAMED
    FDA Recall Terminated

    Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.

    Recall: Z-0648-2010 · Initiated November 6, 2009

    Recall

    Recall Number
    Z-0648-2010
    Event Number
    53779
    Firm
    Spacelabs Healthcare, Incorporated
    FEI Number
    3010157426
    Product Code
    DXJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 6, 2009
    Posted
    January 19, 2010
    Terminated
    July 21, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.

    Reason

    Potential for monitor to shut down and not being able to power on again.

    Action

    On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.

    Distribution

    Worldwide Distribution

    Quantity

    2,023 units