Device recall
Z-0883-2009: Monitor portion of the LifeVest device - specifically the Defibrillator printed…
FDA device recall · Class II · Zoll Lifecor Corporation
Key facts
| Recall number (Z-number) | Z-0883-2009 |
|---|---|
| Recall event | 50119 |
| Product | Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. |
| Product code | MVK |
| Recalling firm | Zoll Lifecor Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2009 |
| PMA numbers | P010030 |
| FEI number | 3008642652 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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