Z-0723-2020 Class II Terminated
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
- 12
Product 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.
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 00636 8 Lot Code: J380208 Model Number: PL00010-60.00-60.00-60.00-60.00-G