Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center

Activity by year

Devices registered here (1)

• Support, Arm
  Product code IOY (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3475

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)

• VAI2024-01-24
  Voluntary 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.

Related

• All facilities operated by NIHON KOHDEN CORP.
• NIHON KOHDEN AMERICA, INC. (CA)
• Nihon Kohden Tomioka Corporation (JP)
• Nihon Kohden Corporation - Eastern Japan Logistics Center (JP)
• NIHON KOHDEN TOMIOKA PRODUCTION CENTER (JP)
• NIHON KOHDEN CORP. (JP)
• Nihon Kohden America Fulfillment Center (CA)
• Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center (JP)
• Nihon Vinyl Cord Corporation - Kodama Second Factory (JP)
• Nihon Kohden Digital Health Solutions, LLC. (CA)
• Nihon Vinyl Cord Corporation - Shimo-ongata Factory (JP)

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)