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Enobio Dx

NEUROELECTRICS BARCELONA SL · Model Kid Neoprene Headcap (size K) - Component Spare Part: Enobio Dx · UDI-DI 18436612823017

GWQ GWL Prescription

510(k) clearances

325

Adverse events (3 deaths)

Recalls

Facilities

Description

This device is the spare part of Enobio Dx's component Kid Neoprene Headcap (size K). It is used to precisely place the electrodes on the scalp for stable recordings with Enobio Dx. Enobio Dx is a wireless battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designated for use in a clinical environment or hospital. Enobio Dx use must be controlled by specialized medical personnel able to guarantee the correct recording.

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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Data 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.