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FDANovember 10, 2015device

Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.

What to do

FDA enforcement status: Terminated

Brands named

c r bard

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures. — Recall Details · AllClear