FDAMay 21, 2020device
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 rep...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
vitalconnect
UPCs
00850490007139
Recall history
No related federal recalls on record for this brand yet.
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