Neurovision recalls Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube (7.0mm) due to potential electrode insulation softening, which may cause EMG signal transmission failure. Affected kits have specific lot numbers.
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.
Neurovision is recalling its Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube (7.0mm) because the electrode insulation may soften over time, potentially causing EMG signals to stop working. This could lead to inaccurate nerve monitoring during surgery or medical 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 block the EMG signal transmission to the monitor, rendering the device unusable for nerve monitoring.
Healthcare professionals using the Nerveana x5 RLN Monitoring Kit for continuous EMG monitoring during surgery or medical procedures. Patients undergoing nerve monitoring surgeries are at risk if the kit fails.
Check for the product name 'Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm' and lot numbers listed in the recall (e.g., 052219E, 052219D, etc.). The kit is sold with a sterile, single-use label and requires a prescription.
Look for the lot numbers listed in the recall (e.g., 052219E, 052219D) on the kit packaging.
Reach out to Neurovision Medical Products Inc for guidance on whether your kit is affected and next steps.
The recall states the electrode insulation may soften over time, which could cause signal failure. Affected kits should be checked for lot numbers and contacted for guidance.
Check the lot number against the list provided in the recall and contact Neurovision Medical Products Inc for specific instructions.
The affected kits have specific lot numbers listed in the recall (e.g., 052219E, 052219D) and are labeled as 'RxOnly, Sterile' with a 7.0mm tube size.
We’ve drafted a message you can send Neurovision to request your refund or repair — edit it as you like.
Subject: Recall Z-2901-2020 — Neurovision Neurovision Hello, I own a Neurovision that is covered by recall Z-2901-2020 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.
