Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0722-2020·Announced 2020-01-01

Lifelines Neuro Recalls ElectroTek EEG Sensor Cables Due to Labeling Error

Lifelines Neuro is recalling eight ElectroTek EEG temporal sensor cables because incorrect placement labels could lead to improper electrode positioning during brain activity studies.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect labeling which could lead to improper electrode placement. There are no reports of injury or death, and the risk is primarily related to data accuracy rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Lifelines Neuro Company is recalling eight units of the ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated. The recall involves a potential defect where one of the four temporal electrode cables used with the ElectroTek EEG system may have incorrect placement labels.

The ElectroTek system is intended to acquire, display, and store the electrical activity of a patient's brain by placing electrodes on the scalp for studies such as electroencephalogram (EEG) and video EEG recording. The incorrect labels could lead to the incorrect placement of electrodes during an EEG study.

The affected units were distributed nationwide in the United States, specifically in the states of Texas, Tennessee, and North Carolina. The specific product code is UDI: 0 0856310 00635 1, Lot Code: J380188, and Model Number: PL00010-29.00-31.75.33.00-35.50-G. Healthcare providers and consumers should stop using the affected cables and contact Lifelines Neuro Company for instructions on how to proceed.

The recalled product

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…
Manufacturer: LIFELINES NEURO COMPANY
Category: Medical Device — EEG Equipment
Hazard: mis-labeling
incorrect-placement
Affected units: 8

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by LIFELINES NEURO COMPANY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · LIFELINES NEURO COMPANY

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Moderate
Lifelines Neuro Recalls ElectroTek Temporal Sensor Cables for Labeling Errors
FDA (Devices) · 2020-01-01

Same hazard · mis labeling