# FDA recall Z-0722-2020

> **LIFELINES NEURO COMPANY** · Class II · device recall initiated 2019-10-11.

## 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.

## 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

- **Recall number:** Z-0722-2020
- **Recalling firm:** LIFELINES NEURO COMPANY
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2020

## Citation

> AI Analytics. FDA recall Z-0722-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0722-2020. Source: US FDA. Licensed CC0.

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