Vitalconnect Inc. recalls VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professional…

Recall date

May 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2537-2020

FDA classification

Class II

Brand / firm

Vitalconnect Inc.

Sold / distributed

U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.