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Neuromaster MEE-2000A-DTRecalls & reported problems

Nihon Kohden America, Inc. · MEE-2000 Neuromaster G1 Desktop system; performs Intraoperative and Evoked Potential studies · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841983103612), received between Jun 27, 2019 and Dec 26, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem4
  • Application Program Problem1
  • Connection Problem1
  • Incomplete or Inadequate Connection1
  • Signal Artifact/Noise1
  • Unintended Application Program Shut Down1

Patient problems

  • No Consequences Or Impact To Patient4
  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 26, 2024Signal Artifact/Noise; Signal Artifact/Noise

    THE CUSTOMER REPORTED A 60 HERTZ ARTIFACT WHILE PERFORMING EMG SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21019733 ↗
  • MalfunctionDec 28, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

    THE CUSTOMER REPORTED THAT WHEN LAUNCHING AN SSEP EXAMINATION IN THE OR (WITH A PATIENT ON THE TABLE), THE MEE 2000 SYSTEM GAVE A "SOMATO HIGH" ERROR MESSAGE FOR THE ELECTRICAL STIMULATOR, THEN SHUT DOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16061918 ↗
  • MalfunctionAug 21, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

    THE CUSTOMER REPORTED THAT THE MEE-2000-DT PERFORMED SEVERAL INSTANCES OF SWITCHING FROM DISCONNECTING AND THEN RECONNECTING TO THE MAIN UNIT DURING A PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10439932 ↗
  • MalfunctionJun 28, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE FRAMES OF THE CART FOR THE MEE-2000A SYSTEM IS COLLAPSING AND CAUSING ISSUES WITH THE WHEELS NOT BEING ALIGNED. THE MEE-2000A IS AN IOM SYSTEM WHICH IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. DEVICE NOT IN USE ON PATIENT AND NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8746630 ↗
  • MalfunctionJun 28, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE FRAMES OF THE CART FOR THE MEE-2000A SYSTEM IS COLLAPSING AND CAUSING ISSUES WITH THE WHEELS NOT BEING ALIGNED. THE MEE-2000A IS AN IOM SYSTEM WHICH IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. DEVICE NOT IN USE ON PATIENT AND NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8746616 ↗
  • MalfunctionJun 28, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE FRAMES OF THE CART FOR THE MEE-2000A SYSTEM IS COLLAPSING AND CAUSING ISSUES WITH THE WHEELS NOT BEING ALIGNED. THE MEE-2000A IS AN IOM SYSTEM WHICH IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. DEVICE NOT IN USE ON PATIENT AND NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8746613 ↗
  • MalfunctionJun 27, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE FRAMES OF THE CART FOR THE MEE-2000A SYSTEM IS COLLAPSING AND CAUSING ISSUES WITH THE WHEELS NOT BEING ALIGNED. THE MEE-2000A IS AN IOM SYSTEM WHICH IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. DEVICE NOT IN USE ON PATIENT AND NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8741369 ↗

Other STIMULATOR, ELECTRICAL, EVOKED RESPONSE devices

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Sources and updates

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