Device recall
Z-0369-06: Alsius CoolGard Temperature Regulation System
FDA device recall · Class III · Alsius Corporation
Key facts
| Recall number (Z-number) | Z-0369-06 |
|---|---|
| Recall event | 34073 |
| Product | Alsius CoolGard Temperature Regulation System |
| Product code | NCX |
| Recalling firm | Alsius Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 5, 2007 |
| 510(k) numbers | K014241, K030421 |
| FEI number | 3002922896 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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