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
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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