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Nihon Kohden America Recalls
10 recalls on record · July 9, 2014 to November 13, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 13, 2024Medical DevicesFDA
Nihon Kohden America Inc recalls Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxyge
Hazard: Due to products being shipped/distributed to customers after the products expiration date had past.
November 6, 2024Medical DevicesFDA
Nihon Kohden America Inc recalls Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Hazard: Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
November 6, 2024Medical DevicesFDA
Nihon Kohden America Inc recalls Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult,
Hazard: Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
June 12, 2024Medical DevicesFDA
Nihon Kohden America Inc recalls BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to
Hazard: Due to software issue the device may give false "SpO2 Probe Failure" alarm
March 10, 2021Medical DevicesFDA
Nihon Kohden America Inc recalls WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 008419831
Hazard: Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
February 3, 2021Medical DevicesFDA
Nihon Kohden America Inc recalls PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UD
Hazard: Medical device non-conformance to electrical safety standard (IEC 60601-1).
April 19, 2017Medical DevicesFDA
Nihon Kohden America Inc recalls Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) comm
Hazard: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
February 24, 2016Medical DevicesFDA
Nihon Kohden America Inc recalls MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B,
Hazard: 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.
May 6, 2015Medical DevicesFDA
Nihon Kohden America Inc recalls Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is
Hazard: Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
July 9, 2014Medical DevicesFDA
Nihon Kohden America Inc recalls CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring
Hazard: 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 that data should they be appropriate.