Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-0723-2020

U.S. FDA — Device Enforcement · United States · 2019-10-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0723-2020
Date of alert: 2019-10-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: LIFELINES NEURO COMPANY
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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