Nevision Medical recalls x5 RLN Monitoring Kit with Cobra EMG ET tube (6.0mm) due to risk of signal loss from electrode insulation softening. Affected kits have specific lot numbers and were sold for nerve monitoring during surgery.
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Nevision Medical is recalling its x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET tube (6.0mm) because the electrode insulation may soften over time, causing signal transmission issues. This could render the device unusable during critical nerve monitoring procedures.
The electrode insulating material on the Cobra EMG ET tube may soften over time, making it more prone to damage from scratching or bending. This could stop or inhibit the EMG signal transmission to the monitor, rendering the device non-functional during critical nerve monitoring procedures.
Healthcare professionals using the kit for continuous EMG monitoring during surgery are most at risk. The recall applies to specific lot numbers of the kit sold for nerve monitoring and airway management.
Check for the product name 'Nevision x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm' and lot numbers listed in the recall (e.g., 070919A, 072619A, etc.). The kit is sold for continuous EMG monitoring during surgery.
Look for the lot numbers listed in the recall: 070919A, 072619A, 073119A, 082019B, 120219D, 120319G, 120519A, 121819E, 121919E, 122019B, 010820D, 011520A, 011620A, 012320D, 012420B, 030620A, 031220E, 052120B, 062620A, 022820A, 041620C, 062520A.
The recall states the electrode insulation may soften over time, potentially causing signal loss. Users should check the lot number and follow the recall steps.
Check the product lot number against the list provided in the recall. If it matches, contact Neurovision Medical for further instructions.
The device is used for continuous EMG monitoring during surgery to assess nerve function and provide airway management. Signal loss could compromise patient safety during critical procedures.
We’ve drafted a message you can send Neurovision to request your refund or repair — edit it as you like.
Subject: Recall Z-2900-2020 — Neurovision Neurovision Hello, I own a Neurovision that is covered by recall Z-2900-2020 from Neurovision. 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.
