BEUDAMED
    FDA Recall Terminated

    BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

    Recall: Z-1089-2007 · Initiated June 5, 2007

    Recall

    Recall Number
    Z-1089-2007
    Event Number
    38128
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 5, 2007
    Posted
    July 23, 2007
    Terminated
    October 29, 2008
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)

    Reason

    Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.

    Action

    Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair.

    Distribution

    International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel

    Quantity

    57