Vitalconnect Inc.: Medical Device Recall in 2020 - (Recall #: Z-2537-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 21, 2020

Date Posted: July 15, 2020

Recall Number: Z-2537-2020

Event ID: 85802

Reason for Recall:

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.

Status: Terminated

Product Quantity: 7

Code Information:

Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139

Distribution Pattern:

U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated