RegWardenFDA facility compliance records
Facility

NIHON KOHDEN TOMIOKA PRODUCTION CENTER

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2016: 1 inspections; 2017: 1 recalls; 2020: 1 recalls; 2021: 1 recalls; 2022: 1 recalls; 2024: 2 recalls1’12’131’141’151’161’17’18’191’201’211’22’232’24’25’26
  • Recalls (9)
  • Inspections (1)

Devices registered here (7)

  • Device, Nerve Conduction Velocity Measurement
    Product code JXE (opens in a new tab) · Class II · Neurology · 21 CFR 882.1550
  • Stimulator, Auditory, Evoked Response
    Product code GWJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1900
  • Device, Galvanic Skin Response Measurement
    Product code GZO (opens in a new tab) · Class II · Neurology · 21 CFR 882.1540
  • Electromyograph, Diagnostic
    Product code IKN (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.1375
  • Stimulator, Electrical, Evoked Response
    Product code GWF (opens in a new tab) · Class II · Neurology · 21 CFR 882.1870
  • Full-Montage Standard Electroencephalograph
    Product code GWQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
  • Stimulator, Photic, Evoked Response
    Product code GWE (opens in a new tab) · Class II · Neurology · 21 CFR 882.1890

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 (1)

  • NAI2016-03-25
    No Action Indicated · Compliance: 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.

Related

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 TOMIOKA PRODUCTION CENTER (FEI 3002807739) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807739-nihon-kohden-tomioka-production-center/

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