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Nihon Kohden America Inc FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, Class IISep 18, 2024Due to oximeters not having FDA market approval or clearance |
| Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, eachClass IISep 18, 2024Due to oximeters not having FDA market approval or clearance |
| BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended toClass IIApr 29, 2024Due to software issue the device may give false "SpO2 Probe |
| Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygeClass IIApr 29, 2022Due to products being shipped/distributed to customers after |
| WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 008419831Class IIJan 8, 2021Incorrect Date Stamp or No Data Transfer on Telemetry Receiv |