FDAFDA · Food and drugs·Recall number Z-0722-2020
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 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.
Published January 1, 2020 · Recall initiated: October 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- LIFELINES NEURO COMPANY
- Distributor
- US Nationwide distribution in the states of TX, TN, NC.
- Lot
- UDI: 0 0856310 00635 1 Lot Code: J380188 Model Number: PL00010-29.00-31.75.33.00-35.50-G
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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