Device recall
Z-1041-2022: Philips Hemodynamic Application, Model Number 722463, Software Version Number…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-1041-2022 |
|---|---|
| Recall event | 89878 |
| Product | Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System. |
| Product code | MWI |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2024 |
| 510(k) numbers | K181311 |
| FEI number | 3016618143 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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