Device recall
Z-1032-2011: SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is…
FDA device recall · Class II · Galil Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1032-2011 |
|---|---|
| Recall event | 57571 |
| Product | SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing… |
| Product code | GEH |
| Recalling firm | Galil Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2012 |
| 510(k) numbers | K021261, K051052 |
| 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