Device recall
Z-1773-2013: The LIFEPAK 500 Automated External Defibrillator is a semi-automatic…
FDA device recall · Class II · Physio Control, Inc.
Key facts
| Recall number (Z-number) | Z-1773-2013 |
|---|---|
| Recall event | 65565 |
| Product | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended… |
| Product code | MKJ |
| Recalling firm | Physio Control, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 19, 2013 |
| 510(k) numbers | K052057 |
| 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