FDA-Device2023-09-27Class II
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
Avanos Medical, Inc.
Hazard
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Sold states
US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of: BRAZIL
Affected count
24 units
Manufactured in
5405 Windward Pkwy, Alpharetta, GA, United States
Products
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2023Don't want to check this manually?
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