Z-2537-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 21, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
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.
Distribution Pattern
U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
Code Information
Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139