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NIHON KOHDEN AMERICA, INC. · Model JL-900P · UDI-DI 00841983100734
10
510(k) clearances
325
Adverse events (3 deaths)
23
Recalls
94
Facilities
Description
SpO2 connection cord (for Nihon Kohden SpO2 probe)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-04 | Micromed S.p.A. | Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuratio |
| 2025-06-18 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Natus received two complaints of left side labeling show impedance for right side. |
| 2024-08-12 | SEER MEDICAL PTY LTD | During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions ma |
| 2023-12-08 | WAVi Co. | Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study. |
| 2020-12-21 | Nihon Kohden America Inc | Medical device non-conformance to electrical safety standard (IEC 60601-1). |
| 2019-10-11 | LIFELINES NEURO COMPANY | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrod |
| 2019-10-11 | LIFELINES NEURO COMPANY | Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrect placement labels which could lead to incorrect placement of electrod |
| 2018-05-15 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting. |
| 2015-11-11 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity. |
| 2015-09-11 | Natus Neurology Inc | When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuri |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.