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LIFELINES NEURO COMPANY recalls ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system Elect
Recalled January 1, 2020 · FDA recall Z-0722-2020 · LIFELINES NEURO
Hazard
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 electrode for an EEG study. · FDA Class II
Units
8
Sold at
US Nationwide distribution in the states of TX, TN, NC.
Description
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 electrode for an EEG study.
Product
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Manufacturer(s)
LIFELINES NEURO COMPANY
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →