Device recall
Z-0963-2015: HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J…
FDA device recall · Class II · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0963-2015 |
|---|---|
| Recall event | 69747 |
| Product | HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical… |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 4, 2019 |
| 510(k) numbers | K031187, K040404, K051134, K061707, K062233, K063375 |
| 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