LIFELINES NEURO COMPANY: Medical Device Recall in 2020 - (Recall #: Z-0723-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 11, 2019

Date Posted: January 1, 2020

Recall Number: Z-0723-2020

Event ID: 84270

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.

Status: Terminated

Product Quantity: 12

Code Information:

UDI: 0 0856310 00636 8 Lot Code: J380208 Model Number: PL00010-60.00-60.00-60.00-60.00-G

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated