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FDAAugust 1, 2023device

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 select...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

What to do

FDA enforcement status: Completed

Brands named

avanos medicalavanos

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 select... — Recall Details · AllClear