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Full-Montage Standard Electroencephalograph
FDA product code GWQ · Class 2 · Neurology
819
Registered devices
325
Adverse events
23
Recalls
189
510(k) clearances
Devices with this code
NA — MEDTRONIC XOMED, INC.PHILIPS BIS Module — Philips Medizin Systeme Böblingen GmbHMicromed — MICROMED SPASeer Home — SEER MEDICAL HOLDINGS LIMITEDNatus — XLTEKLifelines iEEG Portable Yoga Tablet Wired — Kvikna Medical ehf.NA — MEDTRONIC XOMED, INC.Compumedics Neuvo — COMPUMEDICS LIMITEDCascade Elite — CADWELL INDUSTRIES, INC.IOMAX Extender Pod — CADWELL INDUSTRIES, INC.Nihon Kohden, EEG-1200A Series Neurofax — NIHON KOHDEN CORPORATIONCARESCAPE B850 — GE Healthcare Finland OyNeurovirtual — M F Equipamentos Medicos Ltda EppTrackit — LIFELINES LIMITEDSierra Wave — CADWELL INDUSTRIES, INC.CERVELLO 64 — BLACKROCK NEUROMED, LLCX-Series — ADVANCED BRAIN MONITORING, INC.NIM-ECLIPSE® — MEDTRONIC XOMED, INC.iSyncWave — iMediSync, Inc.Natus — NATUS NEUROLOGY INCORPORATEDNA — NIHON KOHDEN AMERICA, INC.Zeto All-in-One Medical Grade PC — ZETO INCmicromed — MICROMED SPAZeto ONE AUX Cable Extension Set — ZETO INC
Recent 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 am |
| 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 r |
| 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 p |
| 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 p |
| 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 ma |
| 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 |
| 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 |
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