Z-0722-2020Class II

ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated -

Name: Z-0722-2020 ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated -
Creator: Lifelines Neuro Company
Published: 2019-10-11
License: https://open.fda.gov/license/

Lifelines Neuro Company / initiated 2019-10-11 / Terminated / root cause: labeling and UDI

FDA source

LIFELINES NEURO COMPANY began a recall of ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display... on 2019-10-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0722-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Posted: 2019-12-20
Terminated: 2020-11-16
Recalling firm: Lifelines Neuro Company
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.
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
Root cause tag: labeling and UDI
FDA root cause: Component change control
Action: On October 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by overnight mail to the consumer/user accounts with replacement cables stating: Please find enclosed six packages of orange Temporal EEG electrode cables for use with your Trackit M system to replace the incorrectly labelled orange Temporal EEG electrode cables. Please discontinue using the orange Temporal Electrode cables that were provided with your Trackit M kit at delivery. Please return all of the orange Temporal Electrode Cables originally provided with the kit to our attention in the postage-paid envelope enclosed herein to assist with our containment and correction of the issue. The incorrectly labelled electrodes to return to our attention are marked by packaging lot #J380188 and #J380208. Please see below for the packaging labels from the lots of electrodes to be replaced. We apologize for the issues and inconvenience caused by this correction. Lifelines Neuro is dedicated to our goal of providing the best client engagement in the industry, acting as a trusted partner to help improve patient care and safety, processes, research, operational efficiency, and financial performance. Should you have any questions or wish to discuss this, please do not hesitate to contact me directly at 812-946-0444.
Quantity in commerce: 8
Distribution: US Nationwide distribution in the states of TX, TN, NC.
Product codes and lots: UDI: 0 0856310 00635 1 Lot Code: J380188 Model Number: PL00010-29.00-31.75.33.00-35.50-G

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0722-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0722-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20
Z-0723-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20

Product code GWQ

K170441Class IIElectroTekMobilemedtek / cleared 2017-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)