Facility

Nihon Kohden Digital Health Solutions, LLC.

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

Key facts

9recalls · worst Class II

2inspections · worst NAI

1warning letters

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

FDA Establishment Identifier (FEI)	3003142870
Establishment type	Manufacture Medical Device
Location	14 Bunsen IRVINE, CA, US 92618
Registration status	Active · expires 2026
Parent company	NIHON KOHDEN CORP. (owner-operator 8030227)
Brand names	NetKonnect Remote Network Extension

Activity by year

Recalls (9)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code MHX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025

Recalls & enforcement

Class IIOngoing2024-09-18
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Class IIOngoing2024-04-29
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Class IIOngoing2022-04-29
Due to products being shipped/distributed to customers after the products expiration date had past.
Class IIOngoing2021-01-08
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Class IIOngoing2020-12-21
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Class IITerminated2017-03-13
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Class IITerminated2015-04-14
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Class IITerminated2014-06-03
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on th…
Class IITerminated2012-01-19
The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.

FDA inspections (2)

NAI2023-06-13
No Action Indicated · Compliance: Devices
NAI2016-05-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

FDA warning letters (1)

Warning Letter2026-06-15
Warning Letter (opens in a new tab) · Irvine California

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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. “Nihon Kohden Digital Health Solutions, LLC. (FEI 3003142870) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003142870-nihon-kohden-digital-health-solutions-ll/

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