Device recall
Z-0029-2022: Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in…
FDA device recall · Class I · Aesthetics Systems Usa Inc
Key facts
| Recall number (Z-number) | Z-0029-2022 |
|---|---|
| Recall event | 88624 |
| Product | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. |
| Product code | ITX |
| Recalling firm | Aesthetics Systems Usa Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K955246 |
| FEI number | 3006482872 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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