Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0723-2020·Announced 2020-01-01

Lifelines Neuro Recalls ElectroTek Temporal Sensor Cables for Labeling Errors

Lifelines Neuro is recalling 12 ElectroTek Temporal Sensor Cables due to potential incorrect placement labels that could lead to improper electrode placement during EEG 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, and the hazard involves minor labeling errors that could lead to incorrect electrode placement, which fits the criteria for moderate severity without reported injuries.

Plain-English summary

Lifelines Neuro Company is recalling 12 units of the ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length. The recall was initiated because there is a potential for one of the four temporal electrode cables used with the ElectroTek EEG system to have incorrect placement labels.

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

The affected units were distributed nationwide in the United States, specifically in the states of Texas, Tennessee, and North Carolina. The product is identified by UDI 0 0856310 00636 8, Lot Code J380208, and Model Number PL00010-60.00-60.00-60.00-60.00-G. Users should contact Lifelines Neuro Company for instructions on how to return or replace the affected cables.

The recalled product

Product: 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…
Manufacturer: LIFELINES NEURO COMPANY
Category: Medical Device — EEG Equipment
Hazard: mis-labeling
Affected units: 12

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 EEG Sensor Cables Due to Labeling Error
FDA (Devices) · 2020-01-01

Same hazard · mis labeling