FDAJune 27, 2024device
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Mod...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
What to do
FDA enforcement status: Ongoing
Brands named
medivance
UPCs
008017411615130080174116152000801741226380008017412263970080174122640300801741080142008017411277550080174108015900801741186134008017411861410080174117000300801741222818
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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