Z-0722-2020 Class II Terminated
FDA device recall Z-0722-2020 was initiated by LIFELINES NEURO COMPANY on October 11, 2019 and is designated Class II. 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. The recall status is terminated (terminated November 16, 2020). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2020
- Initiation Date
- October 11, 2019
- Termination Date
- November 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
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 Pattern
US Nationwide distribution in the states of TX, TN, NC.
Code Information
UDI: 0 0856310 00635 1 Lot Code: J380188 Model Number: PL00010-29.00-31.75.33.00-35.50-G