Vitalconnect VistaSolution Software Recall for Missing SpO2 Notifications
Vitalconnect Inc. is recalling VistaSolution software due to a defect that prevented low SpO2 alerts, potentially exposing patients to short-term hypoxia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is potential hypoxia, but no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Vitalconnect Inc. is recalling VistaSolution, a physiological signal transmitter and software graphical user interface used by healthcare professionals to display physiological data. The software serves as a secondary, adjunct patient monitor in healthcare settings and is not intended to replace standard-of-care patient monitoring. The recall involves 7 units distributed nationwide, including in New Jersey, New York, and Virginia.
The recall was initiated after a healthcare provider identified a patient with a lowered historic SpO2 reading that should have triggered a notification to the care team, but no notification was generated. A software defect caused this 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 performance back into compliance with specifications. Healthcare professionals using this device should contact Vitalconnect Inc. for instructions on the software correction.
The recalled product
- 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…
- Manufacturer
- Vitalconnect Inc.
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog number: 6200
- Vista Solution version 2.1
- UDI: 00850490007139
Distribution
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