Device recall
Z-0175-2019: Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The…
FDA device recall · Class II · Philips Electronics North America Corp.
Key facts
| Recall number (Z-number) | Z-0175-2019 |
|---|---|
| Recall event | 81134 |
| Product | Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable… |
| Product code | MKJ |
| Recalling firm | Philips Electronics North America Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2022 |
| PMA numbers | P160028 |
| FEI number | 1000524572 |
At a glance
- None 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