NIM Vital™ NIM4CPB1 (UDI 00763000002985)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00763000002985), received between Jul 31, 2023 and Aug 28, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (42 reports).

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K200759); 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.

Recalls naming this device

1. Mar 10, 2025Class IIOpen, Classified

   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.

   Z-1623-2025 · Root cause: Software change control · Recall details · FDA record ↗

2. Jun 24, 2024Class IOpen, Classified

   Potential for false negative response on the NIM Vital Nerve Monitoring System

   Z-2409-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 3, 2022Class IIOpen, Classified

   Software anomaly was identified.

   Z-1224-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

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

  MAUDE report 50496330 ↗
• MalfunctionMay 18, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT WHILE HARD WIRE CONNECTED THE UNIT RANDOMLY LOST CONNECTION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25197214 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION STATED THAT NIM CONSOLE WAS WORKING WELL WITH THE ANOTHER PATIENT INTERFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069212 ↗
• MalfunctionApr 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE DOES NOT FUNCTION AT ALL WITH THE NIM VITAL. ERROR MESSAGE MULTIPLE TIMES CHECKED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24797569 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PATIENT SHOWED THE ERROR NOTIFICATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698644 ↗
• MalfunctionMar 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT IN THE NIM4.0 SCREEN IT APPEARED A MESSAGE SAYING, "THERE IS A PROBLEM WITH INTERFACE, TRYING TO SOLVE THE PROBLEM, IF NOT, CONTACT TO THE CUSTOMER SUPPORT". THE PROCEDURE WAS COMPLETED BY USING ANOTHER PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480883 ↗
• MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE NIM PATIENT INTERFACE HAD PI FAULT DETECTED ERROR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289560 ↗
• MalfunctionJan 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TESTING, PATIENT INTERFACE WAS NOT CONNECTING WIRED AND WIRELESSLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069080 ↗
• MalfunctionDec 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  IT WAS REPORTED THAT PATIENT INTERFACE DOESN'T CONNECT WIRELESSLY, IT DOESN'T CHARGE, AND THE DEVICE DOESN'T RECOGNIZE IT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681231 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT NIM PATIENT INTERFACE GIVES THE FAULTING ERROR WHEN UNDOCKED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23616071 ↗
• MalfunctionNov 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE NIM VITAL DID NOT RECOGNIZE THE INTERFACE UNIT. USING THE USUAL PROCEDURE, WHEN REMOVING THE INTERFACE FROM THE CONSOLE, IT WAS NOT RECOGNIZED AND REMAINED RED ON THE SCREEN. ON THAT SAME CONSOLE ANOTHER INTERFACE WAS PLACED, IT WAS PAIRED AND THE SURGERY WAS PERFORMED WITHOUT PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566756 ↗
• MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZED BY CONSOLE. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023101 ↗
• MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TESTING DEVICE WAS GETTING PATIENT INTERFACE FAULT DETECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000755 ↗
• MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS A PI BOX FAULT ERROR CODE ON THE NIM SCREEN, RESET WAS DONE TO THE PI BOX MULTIPLE TIMES AND IT STILL FAULTED, THE CONSOLE WAS WORKING CORRECTLY, THE PROCEDURE WAS COMPLETED BY USING ANOTHER PI BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936543 ↗
• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SERVICING THE PATIENT INTERFACE HAD WIRELESS CONNECTION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892240 ↗
• MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE AUTOMATICALLY FALLS AND SHOWED FATAL MESSAGE AS FAILED TO PAIR WIRELESSLY AND WIRED AND PATIENT INTERFACE FAULT DETECTED. THE CONSOLE WAS WORKING FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628424 ↗
• MalfunctionJul 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT INTERFACE WAS NOT GIVING PROPER SIGNAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628392 ↗
• MalfunctionJul 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CONSOLE-INTERFACE CONNECTION ERROR BOTH VIA CABLE AND WIRELESS MODE. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553173 ↗
• MalfunctionJun 23, 2025Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings; Problem with Software Installation; Failure to Power Up; Incorrect, Inadequate or Imprecise Result or Readings; Problem with Software Installation

  IT WAS REPORTED THAT THE NIM PATIENT INTERFACE HAD USPI CONNECTION ISSUE, IT WILL NOT ESTABLISH A WIRED CONNECTION AND WILL NOT POWER ON OR UPDATE TO THE LATEST SOFTWARE VIA HARD WIRED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22308246 ↗
• MalfunctionJun 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PATIENT SHOWING THE ERROR CODE MESSAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138556 ↗
• MalfunctionFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INTERFACE ERROR IS CONSTANTLY DISPLAYED WHEN CONNECTING THEN IM VITAL CONSOLE TO THE MONITOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462359 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION HAS STATED THAT, TRIED TO CHANGE THE PATIENT INTERFACE AND THE SCREEN FREEZE AND DIDN¿T WORK ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447328 ↗
• MalfunctionDec 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD INTERFACE FAILURE. THERE WAS NO PATIENT INVOLVED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20828582 ↗
• MalfunctionNov 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SERVICING WHILE DOING A SOFTWARE UPGRADE ON THE CONSOLE FROM SW1.5.5 TO 1.6.4, WHICH WENT THROUGH CORRECTLY. BUT WHEN TRIED TO UPDATE THE PI BOX, IT DID NOT GO THROUGH AS IT SHOULD. TRIED SEVERAL TIMES, BUT IT WAS NEGLECTED. THE NOTIFICATION WAS "PATIENT INTERFACE FAULT DETECTED. ATTEMPTING TO RESOLVE. IF PROBLEM PERSISTS, CONTACT TECHNICAL SUPPORT". ALSO TRIED TO UPDATE THE PI THROUGH ANOTHER NIM VITAL CONSOLE WITH THE SW 1.6.4, WITHOUT SUCCESS AND SAME NOTIFICATION. THE PI IS NOW OUT OF USE, AND CAN NOT BE USED WITH ITS CONSOLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782813 ↗
• MalfunctionNov 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200759. One submission often covers many models, so check the product and lot details in each record.

• Z-1223-2022 · May 3, 2022 · Open, Classified
  NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2