Device recall
Z-1858-2008: Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12…
FDA device recall · Class II · Physio Control, Inc.
Key facts
| Recall number (Z-number) | Z-1858-2008 |
|---|---|
| Recall event | 48140 |
| Product | Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic settings. The LIFEPAK 12 has both manual and semi-automatic defibrillation… |
| Product code | MKJ |
| Recalling firm | Physio Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2013 |
| 510(k) numbers | K991910 |
| 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