Device recall
Z-0811-2010: Biphasic LIFEPAK 12 defibrillator / monitor.
FDA device recall · Class II · Physio Control, Inc.
Key facts
| Recall number (Z-number) | Z-0811-2010 |
|---|---|
| Recall event | 54005 |
| Product | Biphasic LIFEPAK 12 defibrillator / monitor. |
| Product code | MKJ |
| Recalling firm | Physio Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2013 |
| 510(k) numbers | K063510 |
| FEI number | 3015876 |
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