Device recall
Z-0642-2013: Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by…
FDA device recall · Class II · Philips Medical Systems North America Co. Phillips
Key facts
| Recall number (Z-number) | Z-0642-2013 |
|---|---|
| Recall event | 63030 |
| Product | Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts… |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems North America Co. Phillips |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2020 |
| 510(k) numbers | K050004 |
| 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