Device recall
Z-2622-2023: COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four…
FDA device recall · Class II · Avanos Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2622-2023 |
|---|---|
| Recall event | 92852 |
| 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… |
| Product code | GXD |
| Recalling firm | Avanos Medical, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K192491 |
| FEI number | 3011270181 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database