Device recall
Z-1776-2010: The Alternans Sensor Kit Assembly is a sealed kit that contains the components…
FDA device recall · Class II · Cambridge Heart, Inc.
Key facts
| Recall number (Z-number) | Z-1776-2010 |
|---|---|
| Recall event | 55505 |
| Product | The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test. |
| Product code | DRX |
| Recalling firm | Cambridge Heart, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2011 |
| 510(k) numbers | K002230 |
| FEI number | 3000215432 |
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