BEUDAMED
    FDA Recall Terminated

    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    Recall: Z-1092-2016 · Initiated February 26, 2016

    Recall

    Recall Number
    Z-1092-2016
    Event Number
    73393
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    February 26, 2016
    Terminated
    October 24, 2016
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    Description

    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    Reason

    The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.

    Action

    Spacelabs sent the letter Urgent Medical Device Correction -Spacelabs Healthcare Inc. - Xhibit Central Station, Model 96102, dated 26 February 2016 to US consignees. The firm will send a notification letter to international consignees on March 4, 2016. Consignees who have any questions about this corrective action, please contact Spacelabs at 1-800-522-7025 and select 2 for Technical Support.

    Distribution

    distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, EL SALVADOR, FRANCE, GERMANY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ITALY, KUWAIT, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and UNITED KINGDOM.

    Quantity

    total 1075 units (614 units in the US and 461 outside the US)