VistaSolution recall: Software Issue
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data…
Why was VistaSolution recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139
- Product
- VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data…
- Recalling firm
- Vitalconnect Inc.
- Quantity
- 7
- Distribution
- U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)