Device recall
Z-1489-2019: Horizon Cardiology Hemo
FDA device recall · Class II · Change Healthcare Israel Ltd.
Key facts
| Recall number (Z-number) | Z-1489-2019 |
|---|---|
| Recall event | 82600 |
| Product | Horizon Cardiology Hemo |
| Product code | DQK |
| Recalling firm | Change Healthcare Israel Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2025 |
| 510(k) numbers | K131497 |
| FEI number | 3007784465 |
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