Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Gene
Recalled 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.
Hazard / Issue
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Issued by
FDA
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