Device recall
Z-0143-2015: Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system…
FDA device recall · Class II · Merge Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-0143-2015 |
|---|---|
| Recall event | 69406 |
| Product | Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data… |
| Product code | DQK |
| Recalling firm | Merge Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2016 |
| 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