RegWardenFDA facility compliance records
Facility

Nihon Kohden Corporation - Eastern Japan Logistics 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; 2017: 1 recalls; 2020: 1 recalls; 2021: 1 recalls; 2022: 1 recalls; 2024: 2 recalls1’12’131’141’15’161’17’18’191’201’211’22’232’24’25’26
  • Recalls (9)

Devices registered here (1)

  • Stimulator, Electrical, Evoked Response
    Product code GWF (opens in a new tab) · Class II · Neurology · 21 CFR 882.1870

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.

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 Corporation - Eastern Japan Logistics Center (FEI 3016852448) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016852448-nihon-kohden-corporation-eastern-japan-l/

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