BEUDAMED
    FDA Recall Terminated

    BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.

    Recall: Z-1619-2008 · Initiated February 27, 2008

    Recall

    Recall Number
    Z-1619-2008
    Event Number
    47495
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    February 27, 2008
    Posted
    August 15, 2008
    Terminated
    December 17, 2011
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.

    Reason

    The Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to

    Action

    Consignees were contacted by an URGENT: Product Safety Information Voluntary Recall Notification letter dated March 11, 2008 with attached Safety Action Bulletin 08-SAB01 dated February 27, 2008 and email between March 7 and March 13, 2008. The consignees will need to return the device to be evaluated in the Smiths Medical PM, Inc.

    Distribution

    Class II Recall - Worldwide Distribution --- USA including states of GA, AL, IL, TX, MI, VA, IA, TN, PA, NC, HI, NY, FL, AZ, OH, CA, MS, UT and Countries: Argentina, Bangladesh, Iran, Thailand, Mexico, India, Germany, Guatemala, Pakistan, Chile, Colombia, Brazil, Saudi Arabia, Morocco, Kuwait, Trinidad and Tobago, Ecuador, Paraguay, Uruguay, Canada, Poland, Portugal, Peru, Qatar, Cyprus, Greece, Italy, Spain, United Arab Emirates, Israel.

    Quantity

    900