Neurosign V4 Intraoperative Nerve Monitor 4230-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060229531858), received between Apr 15, 2021 and Apr 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181559); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2021Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT THERE WAS NO SOUND FROM THE NEUROSIGN V4 DEVICE IN THE MIDDLE OF SURGERY; THERE WAS SOUND IN THE BEGINNING BUT IT DISAPPEARED DURING SURGERY AND SUDDENLY AN YELLOW ICON APPEARED IN THE VOLUME FRAME. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670053 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181559. One submission often covers many models, so check the product and lot details in each record.

• Z-2884-2020 · Jun 23, 2020 · Terminated
  Neurosign V4 Intraoperative Nerve monitor family of devices.