BEUDAMED
    FDA Recall Terminated

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.

    Recall: Z-0831-05 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-0831-05
    Event Number
    31505
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    May 12, 2005
    Terminated
    December 31, 2006
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.

    Reason

    Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.

    Action

    On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).

    Distribution

    CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.

    Quantity

    1