Recall Z-2536-2018 — 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.
U.S. FDA — Device Enforcement · United States · 2018-06-13 · Class II
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Reported risk: An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
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