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 has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
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
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2023