Facility

VitalConnect, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010830833
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2870 Zanker Road San Jose, CA, US 95134
Registration status	Active · expires 2026
Parent company	VitalConnect, Inc. (owner-operator 10046585)
Brand names	VistaSolution

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Transmitters And Receivers, Physiological Signal, Radiofrequency
Product code DRG (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2910

Recalls & enforcement

Class IITerminated2020-05-21
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 i…

FDA inspections (2)

NAI2024-02-15
No Action Indicated · Compliance: Devices
VAI2019-07-25
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by VitalConnect, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VitalConnect, Inc. (FEI 3010830833) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010830833-vitalconnect-inc/

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