Device recall
Z-0485-2011: HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0485-2011 |
|---|---|
| Recall event | 56816 |
| Product | HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121". |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 5, 2013 |
| 510(k) numbers | K003565 |
| FEI number | 1000524572 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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