Device recall
Z-1457-2017: Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring…
FDA device recall · Class II · Merge Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-1457-2017 |
|---|---|
| Recall event | 76447 |
| Product | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. |
| Product code | DQK |
| Recalling firm | Merge Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2019 |
| 510(k) numbers | K082421 |
| FEI number | 1000116130 |
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