Device recall
Z-0729-2017: Merge Cardio software. Merge Cardio is a system intended to be used to acquire…
FDA device recall · Class II · Merge Healthcare, Inc.
Key facts
| Recall number (Z-number) | Z-0729-2017 |
|---|---|
| Recall event | 75825 |
| Product | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of… |
| Product code | LLZ |
| Recalling firm | Merge Healthcare, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 20, 2020 |
| 510(k) numbers | K051649 |
| 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