COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF cha
FDA device recall Z-2622-2023 · posted 2023-09-21 · Completed
Recall details
- Recalling firm
- Avanos Medical, Inc.
- Reason for recall
- Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
- 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.
- Root cause
- Process change control
- Status
- Completed
- Product code
- GXD
- Quantity affected
- 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
- Date initiated
- 2023-08-01
- Date posted
- 2023-09-21
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Coolief Radiofrequency Generator (CRG) System (K192491) | Avanos Medical, Inc. | 2020-02-21 |