BEUDAMED
    FDA Recall Terminated

    Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, printer and battery.

    Recall: Z-0225-06 · Initiated September 1, 2005

    Recall

    Recall Number
    Z-0225-06
    Event Number
    33375
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2005
    Posted
    November 30, 2005
    Terminated
    June 27, 2007
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, printer and battery.

    Reason

    Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.

    Action

    Distirbutors and consignees were notified beginning 09/01/05 via email or phone about Safety Action Bulletin 05-004. Customers were asked to respond to Smiths Medical with a written acknowledgement that they received this Safety Action Bulletin (SAB). The SAB described the issue, actions they should take and instruction on how to have the monitor repaired.

    Distribution

    AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain

    Quantity

    2