FDA Device recall Z-2537-2020
VistaSolution, physiological signal transmitter
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of VistaSolution, physiological signal transmitter by Vitalconnect, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2537-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-21 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vitalconnect |
| Distribution | US |
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 replace existing standard-of-care patient monitoring.
Reason
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 defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.
Identifiers
| code_info | Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2537-2020%22
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