NIM Vital NIM4CM01Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00763000528577), received between Jan 9, 2024 and Sep 29, 2026 — classified as 9 injuries, 251 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (158 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls 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 16, 2026.

Recalls naming this device

1. Mar 10, 2025Open, 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, 2024Open, 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that  the system's PI box "intermittently functions." There is no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931068 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that, the no nerve stimulation from the NIM Console. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868017 ↗
• MalfunctionSep 11, 2026Computer Software Problem; False Negative Result; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733110 ↗
• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; Application Program Freezes or Fails to Launch

  It was reported that both PI boxes displayed the message "PI Box Faulted."  Issue persisted with reboots. Confirmed that the system was plugged into an isolated outlet. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50661783 ↗
• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50502507 ↗
• MalfunctionAug 27, 2026Inappropriate Audible Prompt/Feedback

  It was reported that in a facial nerve monitoring case, there was excessive noise coming from the NIM Vital. There was no known patient impact..

  Patient problems: Insufficient Information

  MAUDE report 50466409 ↗
• MalfunctionAug 26, 2026Inappropriate Audible Prompt/Feedback

  It was reported that during intra-operative the NIM Console alarm goes off all the time. The issue discovered prior to use on the patient. The procedure was completed with the other NIM system. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50447805 ↗
• MalfunctionAug 26, 2026Inappropriate Audible Prompt/Feedback

  Patient problems: Insufficient Information

  MAUDE report 50446673 ↗
• MalfunctionAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430306 ↗
• MalfunctionAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Insufficient Information

  MAUDE report 50407213 ↗
• MalfunctionAug 13, 2026Computer Software Problem; Inappropriate Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232483 ↗
• MalfunctionJul 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET-UP, THE NIM CONSOLE HAD INTERMITTENT AND POOR WIRELESS CONNECTION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713459 ↗
• MalfunctionJul 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN THE PHYSICIAN USES MONOPOLOR ELECTROSURGERY, CH1 AND CH2 DISPLAY "OUT OF MEASUREMENT RANGE AND EMG MONITORING DISABLED ." AFTER SWITCHING TO AND USING THE LIGASURE INSTRUMENT, CH1 AND CH2 RETURN TO NORMAL OPERATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686707 ↗
• MalfunctionJun 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID CASE, WHEN PROVING THE NERVE ON THE LEFT, NO NERVE TONE SOUNDED. AND IT DID ON THE RIGHT SIDE BEFORE DOCTOR SWITCHED SIDES. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25542929 ↗
• MalfunctionJun 8, 2026Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT INTRA-OP DURING THYROIDECTOMY PROCEDURE, THE SCREEN FREEZED AND DIDN'T RESPOND ON TOUCHING. SO, THERE WAS NO POSSIBILITY TO MAKE SCREENSHOTS OR ANYTHING ON THE SCREEN. BUT THE NERVE MONITORING DID WORK, SOUNDS AND ALERTS WERE WORKING TOO. THE SURGERY WAS SUCCESSFULLY COMPLETED, BUT WITHOUT SCREENSHOTS FOR DOCUMENTATION. SHUT DOWN VIA THE SOFTWARE AFTER THE SURGERY WASN´T POSSIBLE. THE ISSUE WAS RESOLVED AFTER THE SURGERY, AS THE SYSTEM FUNCTIONED NORMALLY FOLLOWING A RESTART. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25424932 ↗
• MalfunctionJun 5, 2026Computer Software Problem; Inappropriate Audible Prompt/Feedback; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING PRE-OP, THE NIM VITAL COMPUTER BEGAN FLICKERING AND EMITTING A BEEPING SOUND DURING SHUTDOWN. A HARD SHUTDOWN WAS REQUIRED FOR THE UNIT TO POWER OFF. AFTER REBOOTING, THE ISSUE REOCCURRED ; DISCONNECTED ALL PERIPHERALS AND RESTARTED THE SYSTEM, WHICH INITIALLY RESOLVED THE ISSUE. HOWEVER, AFTER PERFORMING SEVERAL ADDITIONAL REBOOTS TO CONFIRM STABILITY, THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403856 ↗
• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE NIM VITAL DEVICES WERE NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337858 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING INTRA-OP, PLACED THE STIM ON THE NERVE, BUT GOT NO RESPONSE. THEY DOUBLE CHECKED THE TUBE AND ELECTRODE AND STILL HAD NO RESPONSE. THE USER THEN RESECTED FURTHER ON THE NERVE AND INCREASED THE STIM, STILL GETTING NO RESPONSE. USER REMOVED THE THYROID USING HIS KNOWLEDGE AND CHECKED AGAIN, THIS TIME THE DEVICE WAS GETTING A RESPONSE. TRIVANTAGE TUBE WAS BEING USED. IT WAS A LARGER TUBE THAN IS IDEAL FOR THE SIZE OF THE PATIENT. SURGERY WAS EXTENDED FOR LESS THAN AN HOUR. THERE WAS NO IMPACT TO THE PATIENT. THE USER USED SIZE 7 FOR THE PROCEDURE. THERE WAS NO TROUBLE SHOOTING DONE EXCEPT INCREASING THE STIMULUS, LOWERING THRESHOLD, CHECKING TUBE PLACEMENT, AND ENSURING ELECTRODE WERE PLACED CORRECTLY. FACILITY DID NOT CHANGE THE TUBE MID-CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239577 ↗
• MalfunctionMay 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT SOMETIMES THE NIM STARTS UP NORMALLY AND SOMETIMES IT DOESN'T PASS THE SELF-TEST OR IT SHOWS PATIENT INTERFACE FAILURE. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212585 ↗
• MalfunctionMay 18, 2026Computer Software Problem

  IT WAS REPORTED THAT PREOP WHEN BOOTING THE SYSTEM UP, THE CONSOLE DISPLAYS A LOW BATTERY MESSAGE, AND THE SYSTEM SHUTSDOWN SHORTLY AFTER. THE ISSUE PERSISTED ACROSS MULTIPLE ISOLATED OUTLETS AND AFTER CONNECTION WITH WALLPOWER FOR 4 HOURS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211862 ↗
• MalfunctionMay 18, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT PRIOR TO USE THE NIM CONSOLE FUNCTIONALITY OF NERVE TREND WAS NOT WORKING WELL. THE TIMER WASN'T WORKING.  IT REMAINED STUCK AT 11:15 EVEN THOUGH THE PROCEDURE WAS PROGRESSING. THE TROUBLESHOOTING WAS PERFORMED BY RESTARTING BUT ISSUE PERSISTED. THE NIM CONSOLE WAS WELL WORKING, THE ISSUE OCCURRED WHEN THEY TRIED TO DEMONSTRATE THE NEW FUNCTIONALITY NERVE TREND. BUT THE USUAL STIMULATION WAS WORKING WELL AND GIVEN GOOD STIMULATION. THE STIMULUS DELIVERY TONE HEARD WHEN ATTEMPTING TO STIMULATE THE NERVE. WAVEFORM WAS DISPLAYED ON THE MONITOR WHEN ATTEMPTING TO STIMULATE THE NERVE. THE PROCEDURE WAS COMPLETED WITH THE SAME NIM VITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197258 ↗
• MalfunctionMay 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SERVICING, THE SCREEN DISPLAYED "PATIENT INTERFACE FAULT DETECTED. ATTEMPTING TO RESULT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148815 ↗
• MalfunctionMay 8, 2026Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE NIM SYSTEM EXHIBITED CONTINUOUS 'DETECTION' WITH NO APPARENT REASON. CHANGING THE SENSITIVITY THRESHOLD APPEARED TO HAVE NO EFFECT, AND AFTER SEVERAL MINUTES THE SYSTEM RETURNED TO 'NORMAL' OPERATION,WHICH RAISES DOUBTS ABOUT ITS RELIABILITY FOR ITS INTENDED USE.THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123145 ↗
• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET UP PATIENT INTERFACE WAS NOT CONNECTING BOTH WIRED AND WIRELESS TO THE CONSOLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25090576 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT NIM VITAL HAD LOSS OF CONNECTION. ALSO, NOT MUTING WHEN MONOPOLAR WAS ACTIVATED AND DISPLAYED LEAD OFF ERROR MESSAGE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064702 ↗

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
• Z-1224-2022 · May 3, 2022 · Open, Classified
  NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2