Device recall
Z-1548-2011: The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be…
FDA device recall · Class II · Physio Control, Inc.
Key facts
| Recall number (Z-number) | Z-1548-2011 |
|---|---|
| Recall event | 57563 |
| Product | The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a… |
| Product code | MKJ |
| Recalling firm | Physio Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 5, 2012 |
| 510(k) numbers | K010918 |
| 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