Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VistaSolution Recalled by Vitalconnect Inc. Due to A healthcare provider (HCP) noticed a patient had...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vitalconnect Inc. directly.
Affected 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.
Quantity: 7
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vitalconnect Inc.
Vitalconnect Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report