Class II — Vitalconnect Inc.
| Recalling firm | VitalConnect, Inc. |
|---|---|
| Registered facility | VitalConnect, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 not intended to replace existing standard-of-care patient monitoring. |
| Quantity | 7 |
| Distribution | U.S. Nationwide distribution including in the states of NJ, NY, VA, OUS: None |
| Initiated | 2020-05-21 |
| Classified | 2020-07-08 |
| Terminated | 2021-05-13 |
| Recall number | Z-2537-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vitalconnect Inc. (Z-2537-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85802/
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