COOLIEF RF Generator recalls due to F100 and F101 fault complaints
Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with customer complaints of device faults but no reported injuries, hospitalizations, or deaths mentioned in source material. Does not meet criteria for Severe or higher classification.
Plain-English summary
Avanos Medical, Inc. is recalling 24 COOLIEF RF Generator units due to customer complaints of F100 and F101 faults. The COOLIEF RF Generator is an 80-watt radiofrequency device with four independent RF channels and a touch screen interface used in medical lesioning procedures.
The manufacturer has received an increase in complaints regarding these faults. The affected units were distributed to 17 U.S. states: Arizona, California, Georgia, Iowa, Indiana, Kansas, Louisiana, Minnesota, North Carolina, New Mexico, New York, Ohio, Oregon, Texas, Virginia, and Vermont, as well as to Brazil.
Devices with the following serial number codes are affected: STZ22277-006 through STZ22277-029 and STZ22318-001.
The recalled product
- 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
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- STZ22277-006
- STZ22277-007
- STZ22277-008
- STZ22277-009
- STZ22277-010
- STZ22277-011
- STZ22277-012
- STZ22277-013
- STZ22277-014
- STZ22277-015
- STZ22277-016
- STZ22277-017
- STZ22277-018
- STZ22277-019
- STZ22277-020
- STZ22277-021
- STZ22277-022
- STZ22277-023
- STZ22277-024
- STZ22277-025
Distribution
Distributed in 16 states:
- AZ
- CA
- GA
- IA
- IN
- KS
- LA
- MN
- NC
- NM
- NY
- OH
- OR
- TX
- VA
- VT
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