Device recall
Z-0320-2016: Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M…
FDA device recall · Class II · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-0320-2016 |
|---|---|
| Recall event | 72344 |
| Product | Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. |
| Product code | MKJ |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2018 |
| 510(k) numbers | K031187, K040404, K051134, K061707, K062233 |
| FEI number | 1218950 |
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