BEUDAMED
    FDA Recall Terminated

    Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.

    Recall: Z-2902-2011 · Initiated June 8, 2011

    Recall

    Recall Number
    Z-2902-2011
    Event Number
    59136
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    CBR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 8, 2011
    Posted
    August 1, 2011
    Terminated
    September 21, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.

    Reason

    Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.

    Action

    Spacelabs Healthcare, Llc. sent a "Customer Bulletin" dated June 20, 2011 to all affected customers. The customers were notified of the trend problem and are advised to follow the instructions in the Perioperative section and the ADMIT/DISCHARGE section of the users manual. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support or 1-425-657-7200 x5089.

    Distribution

    Worldwide Distribution: (USA) Nationwide distribution, and the countries of ARGENTINA, BAHRAIN, BOLIVIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, ECUADOR, EGYPT, FRANCE, INDIA, MEXICO, NICARAGUA, PARAGUAY, PERU, POLAND, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, CHINA, THAILAND, UNITED ARAB EMIRATES, U.K., URUGUAY, VENEZUELA, and VIETNAM.

    Quantity

    481 units worldwide (333 units internationally and 148 units in the US)