Recall Z-2537-2020— Vitalconnect Inc.

Name: FDA recall Z-2537-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-21

Class II · Terminated

Class II FDA medical device recall by Vitalconnect Inc., initiated 2020-05-21, terminated 2021-05-13. It names one FDA 510(k) clearance: K193343. 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: 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..

Recalling firm: Vitalconnect Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-05-21
Terminated: 2021-05-13
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)Vitalconnect, Inc.·cleared 2020-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.