Lifelines Neuro recalls ElectroTek Temporal Sensor Cable Gold for potential incorrect electrode labels during EEG studies. This could lead to misplacement of electrodes and affect diagnosis. Affected units have specific model and lot codes.
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.
Lifelines Neuro is recalling ElectroTek Temporal Sensor Cables due to possible incorrect labeling of electrode placement. This could cause misplacement during EEG studies, potentially affecting diagnosis accuracy. The recall affects specific model and lot numbers sold for EEG systems.
The cables may have incorrect placement labels, which could lead to electrodes being placed in the wrong position during EEG studies. This might result in inaccurate brain activity readings and affect diagnosis. However, the risk is not described as causing serious injury.
Users of the ElectroTek EEG system who have the specific model PL00010-60.00-60.00-60.00-60.00-G with lot code J380208 are most at risk. Healthcare professionals performing EEG studies may be affected.
Check for the model number PL00010-60.00-60.00-60.00-60.00-G and lot code J380208 on the cable packaging. The product was sold for EEG studies with the electroencephalographic system.
Look for the model number PL00010-60.00-60.00-60.00-60.00-G and lot code J380208 on the cable packaging.
The recall is due to potential incorrect placement labels on the temporal electrode cables, which could lead to misplacement of electrodes during EEG studies.
The affected model number is PL00010-60.00-60.00-60.00-60.00-G.
Check for the model number PL00010-60.00-60.00-60.00-60.00-G and lot code J380208 on the cable packaging.
We’ve drafted a message you can send Lifelines Neuro to request your refund or repair — edit it as you like.
Subject: Recall Z-0723-2020 — Lifelines Neuro Lifelines Neuro Hello, I own a Lifelines Neuro that is covered by recall Z-0723-2020 from Lifelines Neuro. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
