BEUDAMED
    FDA Enforcement Class II Terminated

    Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.

    Recall: Z-2536-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2536-2018
    Event ID
    80375
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Medical Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    June 13, 2018
    Classification Date
    July 24, 2018
    Termination Date
    February 16, 2021
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.

    Reason

    An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.

    Code Info

    Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, 5000-01-08. All serial numbers are affected.

    Distribution

    Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, Brussels China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Guam, Hungary, Iran, Italy, Jordan, Korea, Luxemburg, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Vietnam.

    Quantity

    5608 Units Total