ElectroTek Temporal Sensor Cable Gold — Class II medical device recall Z-0722-2020
Terminated recall by LIFELINES NEURO COMPANY, reported 2020-01-01, distributed nationwide. Potential for one of the four temporal electrode cables used in with the ElectroTek EEG system having incorrec
| Recall number | Z-0722-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LIFELINES NEURO COMPANY, Louisville, KY, United States |
| Recall initiated | 2019-10-11 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2020-11-16 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Reason classes | labeling |
| Lot numbers | J380188 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0722-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.