BEUDAMED
    FDA Recall Terminated

    BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc

    Recall: Z-1240-2007 · Initiated July 18, 2007

    Recall

    Recall Number
    Z-1240-2007
    Event Number
    38472
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2007
    Posted
    September 21, 2007
    Terminated
    October 31, 2008
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc

    Reason

    Phantom pacer spikes caused by a damaged resistor.

    Action

    Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework.

    Distribution

    World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China.

    Quantity

    178