Device recall
Z-2337-2008: HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-2337-2008 |
|---|---|
| Recall event | 48975 |
| Product | HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256Mbyte internal memory card with date code "0308. The product is used for the termination of ventricular tachycardia and ventricular fibrillation. |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2017 |
| 510(k) numbers | K031187 |
| 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