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Recall Observatory FDA recall evidence

Device product

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.

Z-2536-2018

June 13, 2018

Class II

Product summary

Firm
Bard Medical Division
Event
Event 80375
Status
Terminated
Classification
Class II
Quantity
5608 Units Total
Official record key
device-enforcement:Z-2536-2018

Official wording

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 information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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