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 replac
Check against the official notice below — it lists the full affected range.
Vitalconnect Inc. is recalling VistaSolution, a software interface used by healthcare professionals to display physiological data from wireless monitors. A healthcare provider discovered that the software failed to send a notification to the care team when a patient's oxygen saturation (SpO2) reading dropped to a dangerously low level. The defect resulted from a software malfunction that prevented the alert system from functioning properly, potentially leaving patients exposed to hypoxia for a brief period.
The recall affects 7 units of VistaSolution version 2.1 (Catalog number 6200) that were distributed nationwide across New Jersey, New York, and Virginia. Vitalconnect is correcting the software to restore it to proper working specifications. The source does not specify a remedy or action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None Quantity: 7 Lot/code info: Catalog number: 6200, Vista Solution version 2.1, UDI: 00850490007139
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.