Device recall
Z-0404-2020: Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile…
FDA device recall · Class II · Galil Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0404-2020 |
|---|---|
| Recall event | 84120 |
| Product | Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the… |
| Product code | GEH |
| Recalling firm | Galil Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2020 |
| 510(k) numbers | K113860, K123865, K143564 |
| 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