BEUDAMED
    FDA Recall Terminated

    S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.

    Recall: Z-1161-2008 · Initiated December 13, 2007

    Recall

    Recall Number
    Z-1161-2008
    Event Number
    46204
    Firm
    GE Healthcare
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 13, 2007
    Posted
    June 24, 2008
    Terminated
    August 13, 2013
    Address
    9900 Innovation Drive, Wauwatosa, WI, 53226

    Description

    S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.

    Reason

    Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.

    Action

    Consignees were notified via a Medical Device Correction letter on 12/13/07. The letter explained the circumstances in which the "connection to monitor loss" alarm would not display, if a monitor was disconnected. The letter also included an attachment entitled "How to ensure a 'Connection to monitor lost' alarm on iCentral." For additional information, contact 1-800-558-7044.

    Distribution

    Worldwide Distribution including USA states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, PA, SC, TN, TX, VA, VT, WA and WI; and countries of Algeria, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Guans, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen.

    Quantity

    2146