FDA-Device2018-08-01Class II
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.
Bard Medical Division
Hazard
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Sold states
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.
Affected count
5608 Units Total
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2536-2018Don't want to check this manually?
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