FDA Device recall Z-2622-2023
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activat…
- FDA Device
- Class II
- completed
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activat… by Avanos Medical, citing avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2622-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-08-01 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Avanos Medical |
| Distribution | AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT |
Product
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.
Reason
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Identifiers
| code_info | STZ22277-006, STZ22277-007, STZ22277-008, STZ22277-009, STZ22277-010, STZ22277-011, STZ22277-012, STZ22277-013, STZ2227…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2023%22
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