Device recall
Z-2110-2009: Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated…
FDA device recall · Class II · Physio Control, Inc.
Key facts
| Recall number (Z-number) | Z-2110-2009 |
|---|---|
| Recall event | 53087 |
| Product | Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring… |
| Product code | DXN |
| Recalling firm | Physio Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2012 |
| 510(k) numbers | K082937 |
| FEI number | 3015876 |
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