Device recall
Z-2650-2023: IceCure Cryoablation System ProSense -Intended for cryogenic destruction of…
FDA device recall · Class II · Icecure Medical Ltd
Key facts
| Recall number (Z-number) | Z-2650-2023 |
|---|---|
| Recall event | 92945 |
| Product | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC) |
| Product code | GEH |
| Recalling firm | Icecure Medical Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K102360 |
| FEI number | 3008797959 |
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