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.
Recall
- Recall Number
- Z-0723-2020
- Event Number
- 84270
- Firm
- LIFELINES NEURO COMPANY
- FEI Number
- 3015491430
- Product Code
- GWQ
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- October 11, 2019
- Terminated
- November 16, 2020
- Address
- 900 E Main St, Louisville, KY, 40206
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.
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.
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.
US Nationwide distribution in the states of TX, TN, NC.
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