Recall Z-0723-2020 ยท GWQ Full-Montage Standard Electroencephalograph
LIFELINES NEURO COMPANY
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 to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosi
| Date | Oct 11, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Component change control |
| Action | On October 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by overnight mail to the consumer/user accounts with replacement cables stating: Please find enclosed six packages of orange Temporal EEG electrode cables for use with your Trackit M system to replace the incorrectly labelled orange Temporal EEG electrode cables. Please discontinue using the orange Temporal Electrode cables that were provided with your Trackit M kit at delivery. Please return all of the orange Temporal Electrode Cables originally provided with the kit to our attention in the postage-pa |
| Quantity | 12 |
| Distribution | US Nationwide distribution in the states of TX, TN, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170441 | ElectroTek Mobilemedtek, Jun 5, 2017 |