Device recall
Z-2488-2019: HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2488-2019 |
|---|---|
| Recall event | 83576 |
| Product | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual… |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2022 |
| 510(k) numbers | 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