FDA-Device2020-07-15Class II
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.
Vitalconnect Inc.
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.
Sold states
U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
Affected count
7
Manufactured in
224 Airport Pkwy Ste 300, San Jose, CA, United States
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 system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2537-2020Don't want to check this manually?
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