Device recall
Z-2537-2020: VistaSolution, physiological signal transmitter. A software graphical user…
FDA device recall · Class II · Vitalconnect Inc.
Key facts
| Recall number (Z-number) | Z-2537-2020 |
|---|---|
| Recall event | 85802 |
| Product | VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to… |
| Product code | DRG |
| Recalling firm | Vitalconnect Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2021 |
| 510(k) numbers | K193343 |
| FEI number | 3010830833 |
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