Device recall
Z-0941-2015: CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The…
FDA device recall · Class II · CSA Medical
Key facts
| Recall number (Z-number) | Z-0941-2015 |
|---|---|
| Recall event | 69806 |
| Product | CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either… |
| Product code | GEH |
| Recalling firm | CSA Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2015 |
| 510(k) numbers | K133258 |
| FEI number | 3010140265 |
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