Device recall
Z-1144-2017: LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by…
FDA device recall · Class II · Physio-Control, Inc.
Key facts
| Recall number (Z-number) | Z-1144-2017 |
|---|---|
| Recall event | 76162 |
| Product | LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. |
| Product code | MKJ |
| Recalling firm | Physio-Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2018 |
| 510(k) numbers | K142430 |
| 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