Device recall
Z-0011-2013: Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-0011-2013 |
|---|---|
| Recall event | 63116 |
| Product | Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a… |
| Product code | MKJ |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2020 |
| 510(k) numbers | K021453 |
| 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