Louisville, KY, United States
LIFELINES NEURO COMPANY recalls
1 recall recorded since 2018, most recently on 11 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 October 2019
- Terminated
- 16 November 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0722-2020, Z-0723-2020
- 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 obtain
- 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 ob
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.