Device recall
Z-2053-2020: Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product…
FDA device recall · Class II · Philips North America, LLC
Key facts
| Recall number (Z-number) | Z-2053-2020 |
|---|---|
| Recall event | 85147 |
| Product | Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or… |
| Product code | MKJ |
| Recalling firm | Philips North America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2021 |
| 510(k) numbers | K001725 |
| 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