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Vitalconnect Inc. recalls VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professional
Recalled July 15, 2020 · FDA recall Z-2537-2020 · Vitalconnect
Hazard
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. · FDA Class II
Units
7
Sold at
U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
Description
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.
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.
Manufacturer(s)
Vitalconnect Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →