Device recall
Z-1159-04: Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
FDA device recall · Class II · Alsius Corporation
Key facts
| Recall number (Z-number) | Z-1159-04 |
|---|---|
| Recall event | 29538 |
| Product | Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 |
| Product code | NCX |
| Recalling firm | Alsius Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2004 |
| 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