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 diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 0 0856310 00636 8 Lot Code: J380208 Model Number: PL00010-60.00-60.00-60.00-60.00-G
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- LIFELINES NEURO COMPANY
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 diagnosis. The ElectroTek does not draw any diagnostic conclusions.
Product Codes/Lot Numbers:
UDI: 0 0856310 00636 8 Lot Code: J380208 Model Number: PL00010-60.00-60.00-60.00-60.00-G
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0723-2020
Related Recalls
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.