Device recall
Z-1993-2016: LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed…
FDA device recall · Class II · Physio-Control, Inc.
Key facts
| Recall number (Z-number) | Z-1993-2016 |
|---|---|
| Recall event | 73473 |
| Product | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor… |
| Product code | MKJ |
| Recalling firm | Physio-Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2017 |
| 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