Nihon Kohden America recalls
Nihon Kohden America appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 11 |
|---|---|
| Published | 2014-07-09 to 2026-10-14 |
| By agency | FDA Device (11) |
| By classification | Class II (11) |
| By status | ongoing (7), terminated (4) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03,…
FDA Device · Class II · 2026-10-14 · Nihon Kohden America
Reason: Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms. - Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who ca…
FDA Device · Class II · 2024-11-13 · Nihon Kohden America
Reason: Due to products being shipped/distributed to customers after the products expiration date had past. - Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
FDA Device · Class II · 2024-11-06 · Nihon Kohden America
Reason: Due to oximeters not having FDA market approval or clearance to distribute in the U.S. - Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp
FDA Device · Class II · 2024-11-06 · Nihon Kohden America
Reason: Due to oximeters not having FDA market approval or clearance to distribute in the U.S. - BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and…
FDA Device · Class II · 2024-06-12 · Nihon Kohden America
Reason: Due to software issue the device may give false "SpO2 Probe Failure" alarm - WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
FDA Device · Class II · 2021-03-10 · Nihon Kohden America
Reason: Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. - PSG-1100 Sleep Diagnostic System
FDA Device · Class II · 2021-02-03 · Nihon Kohden America
Reason: Medical device non-conformance to electrical safety standard (IEC 60601-1). - Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-62…
FDA Device · Class II · 2017-04-19 · Nihon Kohden America
Reason: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. - MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifier…
FDA Device · Class II · 2016-02-24 · Nihon Kohden America
Reason: 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. - Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40
FDA Device · Class II · 2015-05-06 · Nihon Kohden America
Reason: Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. - CNS-6200 Series Central Nurse Station and accessories
FDA Device · Class II · 2014-07-09 · Nihon Kohden America
Reason: 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…