Device recall
Z-2100-2016: LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s)…
FDA device recall · Class II · Physio-Control, Inc.
Key facts
| Recall number (Z-number) | Z-2100-2016 |
|---|---|
| Recall event | 74198 |
| Product | LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest. |
| Product code | MKJ |
| Recalling firm | Physio-Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2018 |
| 510(k) numbers | K033275 |
| 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