Medtronic Xomed recalls NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier due to potential increased nerve monitoring artifacts, which may cause procedure delays and medical interventions.
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Medtronic Xomed is recalling NIM Vital Nerve Monitoring Systems with software versions v1.6.4 or earlier. These systems may cause increased nerve monitoring artifacts, leading to procedure delays and medical interventions. Affected users should check their software version and contact Medtronic for updates.
The software versions v1.6.4 or earlier may cause increased nerve monitoring artifacts. This can lead to procedure delays and require medical intervention, but does not pose an immediate risk of injury.
Healthcare providers using the NIM Vital Nerve Monitoring System with software versions v1.6.4 or earlier are most at risk. This includes hospitals and clinics that have installed these systems.
Check for the console model NIM4CM01 or NIM4CM01RF, patient interface NIM4CPB1 or NIM4CPB1RF, or software versions v1.6.4 or earlier. The product was sold with specific reference numbers listed in the recall notice.
Review the software version on your NIM Vital Nerve Monitoring System to determine if it is v1.6.4 or earlier.
Reach out to Medtronic Xomed for guidance on updating the software or other remedies.
Software versions v1.6.4 or earlier are affected.
Check the console model (NIM4CM01 or NIM4CM01RF), patient interface (NIM4CPB1 or NIM4CPB1RF), or software version on your NIM Vital Nerve Monitoring System.
Contact Medtronic Xomed for software updates or other remedies.
We’ve drafted a message you can send Medtronic Xomed to request your refund or repair — edit it as you like.
Subject: Recall Z-1623-2025 — Medtronic Xomed Medtronic Xomed Hello, I own a Medtronic Xomed that is covered by recall Z-1623-2025 from Medtronic Xomed. 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.