FDA recall Z-0723-2020

LIFELINES NEURO COMPANY · Class II · device

Product

ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - 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.

Reason for recall

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.

Distribution

US Nationwide distribution in the states of TX, TN, NC.

Key facts

Status
Terminated
Initiation date
2019-10-11
Report date
2020-01-01
Termination date
2020-11-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2020