San Jose, CA, United States
Vitalconnect Inc. recalls
1 recall recorded since 2018, most recently on 21 May 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 21 May 2020
- Terminated
- 13 May 2021
- 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.
- Distribution
- U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2537-2020
- 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 set
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.