FDA-Device2020-03-25Class II
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
LivaNova USA Inc.
Hazard
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Sold states
U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none
Affected count
Total Worldwide=9309 systems (2713 system in U.S.)
Manufactured in
14401 W 65th Way, Arvada, CO, United States
Products
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1498-2020Don't want to check this manually?
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