Drug recall
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare…
FDA recall event 85802 · Class II · Vitalconnect Inc.
Key facts
| Event ID | 85802 |
|---|---|
| Recall numbers | Z-2537-2020 |
| Recalling firm | Vitalconnect Inc. |
| Product type | Devices |
| Products | VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software… |
| Initiation date | May 21, 2020 |
| Report date | Jul 15, 2020 |
| Termination date | May 13, 2021 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 3010830833 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: