# FDA recall Z-2537-2020

> **Vitalconnect Inc.** · Class II · device recall initiated 2020-05-21.

## Product

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.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2537-2020
- **Recalling firm:** Vitalconnect Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-21
- **Report date:** 2020-07-15
- **Termination date:** 2021-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2537-2020

## Citation

> AI Analytics. FDA recall Z-2537-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2537-2020. Source: US FDA. Licensed CC0.

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