Recall Z-2622-2023 ยท GXD Generator, Lesion, Radiofrequency
Avanos Medical, Inc.
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.
| Date | Sep 21, 2023 (initiated Aug 1, 2023) |
| Status | Completed |
| Reason | Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults. |
| Root cause | Process change control |
| Action | 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 CUS |
| Quantity | 24 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192491 | Coolief Radiofrequency Generator (CRG) System Avanos Medical, Inc., Feb 21, 2020 |