Device recall
Z-1780-2008: Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-1780-2008 |
|---|---|
| Recall event | 47833 |
| Product | Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wappingers Falls, NY and is sold outside the U.S. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads. |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2012 |
| 510(k) numbers | K020715 |
| FEI number | 1000524572 |
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