Device recall
Z-0978-2018: HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a…
FDA device recall · Class III · Philips Electronics North America Corporation
Key facts
| Recall number (Z-number) | Z-0978-2018 |
|---|---|
| Recall event | 79191 |
| Product | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a… |
| Product code | MKJ |
| Recalling firm | Philips Electronics North America Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 7, 2020 |
| 510(k) numbers | K110825 |
| 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