Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0760-2016 — Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

U.S. FDA — Device Enforcement · United States · 2015-11-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0760-2016
Date of alert
2015-11-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
C.R. Bard, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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