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.
Recall
- Recall Number
- Z-2622-2023
- Event Number
- 92852
- Firm
- Avanos Medical, Inc.
- FEI Number
- 3011270181
- Product Code
- GXD
- Status
- Completed
- Root Cause
- Process change control
- Initiated
- August 1, 2023
- Posted
- September 21, 2023
- Address
- 5405 Windward Pkwy, Alpharetta, GA, 30004-3894
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.
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
AVANOS issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 08/01/2023 via email. The notice explained the reason for the recall, the potential hazard, and requested the following actions: Identify and return the device in accordance with the instructions provided in the customer response form. Distributors were directed to notify their customers. Discontinue use of the COOLIEF* RF Generators identified below. Complete and return the attached CUSTOMER RESPONSE FORM to [email protected] Return the affected CRG(s) using the instructions provided in the attached CUSTOMER RESPONSE FORM. Our Customer Service team will work with you to provide a replacement COOLIEF* RF Generator. Avanos's goal is to minimize disruption of your facility while prioritizing the safety of your patients. If you have any questions, call 470-448-5591.
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
24 units