Home / Recalls / LIFELINES NEURO COMPANY / Z-0722-2020

Z-0722-2020 Class II Terminated

Recalled by LIFELINES NEURO COMPANY — Louisville, KY

Recall Details

Product Type: Devices
Report Date: January 1, 2020
Initiation Date: October 11, 2019
Termination Date: November 16, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8

Product Description

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.

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 Pattern

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

Code Information

UDI: 0 0856310 00635 1 Lot Code: J380188 Model Number: PL00010-29.00-31.75.33.00-35.50-G