Device recall
Z-0761-2017: The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical…
FDA device recall · Class II · Physio-Control, Inc.
Key facts
| Recall number (Z-number) | Z-0761-2017 |
|---|---|
| Recall event | 75743 |
| Product | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX |
| Product code | MKJ |
| Recalling firm | Physio-Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 16, 2016 |
| 510(k) numbers | K082937 |
| 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