Recall Z-2622-2023— Avanos Medical, Inc.

Name: FDA recall Z-2622-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-01

Class II · Completed

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2023-08-01. It names one FDA 510(k) clearance: K192491. 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.. Reason: Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults..

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Completed
Initiated: 2023-08-01
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K192491 — Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc.·cleared 2020-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.