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Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha
Recalled September 27, 2023 · FDA recall Z-2622-2023 · Avanos Medical
Hazard
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. · FDA Class II
Units
24 units
Sold at
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
Description
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Product
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.
Manufacturer(s)
Avanos Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →