FDA recall Z-2622-2023

Avanos Medical, Inc. · Class II · device

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 for recall

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

Distribution

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

Key facts

Status
Completed
Initiation date
2023-08-01
Report date
2023-09-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2023