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.
This recall has been completed (originally issued September 21, 2023).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- August 1, 2023
- Posted
- September 21, 2023
- Recall Number
- Z-2622-2023
- Quantity
- 24 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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, STZ22277-026, STZ22277-027, STZ22277-028, STZ22277-029, STZ22318-001
Root Cause
Process change control
Action Taken
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 FieldActionCare@avanos.com 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.