Device recall
Z-2261-2012: Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil…
FDA device recall · Class II · Galil Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2261-2012 |
|---|---|
| Recall event | 62871 |
| Product | Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE… |
| Product code | GEH |
| Recalling firm | Galil Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2012 |
| 510(k) numbers | K113860 |
| FEI number | 3004462490 |
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