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.
Enforcement
- Recall Number
- Z-2537-2020
- Event ID
- 85802
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Vitalconnect Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 15, 2020
- Initiation Date
- May 21, 2020
- Classification Date
- July 8, 2020
- Termination Date
- May 13, 2021
- Address
- 224 Airport Pkwy Ste 300, San Jose, CA, 95110-1022, United States
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.
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.
Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139
U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
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