Device recall
Z-1417-2017: HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A…
FDA device recall · Class I · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-1417-2017 |
|---|---|
| Recall event | 76545 |
| Product | HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 17, 2020 |
| 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