Device recall
Z-2072-2025: Change Healthcare Cardiology Hemodynamics Software
FDA device recall · Class II · CHANGE HEALTHCARE CANADA COMPANY
Key facts
| Recall number (Z-number) | Z-2072-2025 |
|---|---|
| Recall event | 97046 |
| Product | Change Healthcare Cardiology Hemodynamics Software |
| Product code | MWI |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K230881 |
| FEI number | 3003757840 |
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