Reported Jul 15, 2020 · Terminated
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare…
Vitalconnect Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vitalconnect Inc. · 224 Airport Pkwy Ste 300 · San Jose, CA · 95110-1022
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog number
6200Vista Solution version 2.1
- UDI00850490007139
- Catalog number
- Amount recalled
- 7
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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