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U.S. Department of Health and Human Services

Class 2 Device Recall COOLIEF RF Generator, REF CRGADVANCED; Radiofrequency Generator (CRG) System

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 Class 2 Device Recall COOLIEF RF Generator, REF CRGADVANCED; Radiofrequency Generator (CRG) Systemsee related information
Date Initiated by FirmAugust 01, 2023
Date PostedSeptember 21, 2023
Recall Status1 Completed
Recall NumberZ-2622-2023
Recall Event ID 92852
510(K)NumberK192491 
Product Classification Generator, lesion, radiofrequency - Product Code GXD
ProductCOOLIEF 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.
Code Information 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
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact
470-448-5591
Manufacturer Reason
for Recall		Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA Determined
Cause 2		Process change control
ActionAVANOS 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.
Quantity in Commerce24 units
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = GXD
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