Reported Jan 1, 2020 · Terminated
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system…
Lifelines Neuro Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LIFELINES NEURO COMPANY · 900 E Main St · Louisville, KY · 40206
Is this the product you have?
- ElectroTek Temporal Sensor Cable Gold - Long Length
- Graduated - Product UsageThe 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
- Lot codes and dates
- UDI0 0856310 00635 1
- Lot CodeJ380188
- Model NumberPL00010-29.00-31.75.33.00-35.50-G
- Amount recalled
- 8
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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