Device recall
Z-0487-2011: HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0487-2011 |
|---|---|
| Recall event | 56816 |
| Product | HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External… |
| 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