NeurofaxRecalls & reported problems across all models
Nihon Kohden Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 2
- Injuries reported
- 2
- Recalls
- 0
We found 2 models of Neurofax by Nihon Kohden Corporation in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2017 and Sep 16, 2025 — classified as 2 deaths, 2 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Neurofax problems
Device problems
- Temperature Problem5
- Application Program Problem4
- Output Problem4
- Overheating of Device4
- Smoking4
- Alarm Not Visible3
- Application Program Freezes or Fails to Launch3
- No Audible Alarm3
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Death2
- Unspecified Tissue Injury2
- Patient Problem/Medical Problem1
Neurofax models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Neurofax EEG-1200ANon-normalizing quantitative electroencephalograph software2 deaths25 reports
- Neurofax EEG-1260ANon-normalizing quantitative electroencephalograph software4 reports
Recent Neurofax adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2025Smoking; Output Problem; Smoking; Output Problem
THE CUSTOMER REPORTED THAT UPS USED WITH THE EEG STARTED SMOKING WHEN IT WAS POWERED ON. THIS WAS AN OUT OF BOX FAILURE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069320 ↗MalfunctionJun 20, 2025Failure to Deliver Shock/Stimulation; Electrical /Electronic Property Problem; Failure to Deliver Shock/Stimulation; Electrical /Electronic Property Problem
THE EEG TECHNICIAN REPORTED THAT THE ARTIFACT WAS NOT SHOWN CORRECTLY DURING A PROCEDURE AND THE PATIENT HAD NO RESPONSE TO THE STIMULATION WHEN THEY SHOULD HAVE. THEY TRIED USING A DIFFERENT GRASS STIM SYSTEM AND THE PATIENT RESPONDED TO THAT ONE. IT WAS NOTED THERE WAS A DIFFERENCE IN PULSE WIDTH FROM OUR SYSTEM TO THE GRASS SYSTEM. THERE WAS NO PATIENT HARD REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302394 ↗MalfunctionJun 5, 2025Unintended Application Program Shut Down; Unintended Application Program Shut Down
THE CUSTOMER REPORTED THAT THE EEG SYSTEM HAD CRASHED DURING A PHASE 2 EEG EXAM, AND THEY NEEDED HELP RETRIEVING THE PATIENT'S CUSTOM PROTOCOL. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148917 ↗MalfunctionMay 9, 2024Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282102 ↗MalfunctionJan 4, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch
THE AMBULATORY CARE CLINICAL MANAGER REPORTED THAT THE CAMERA AND APPLICATION FREEZES CAUSING DATA AND VIDEO LOSS IN EMU ROOM 5. THERE IS AN ERROR MESSAGE THAT APPEARS WHEN THIS HAPPENS. THEY HAVE TO DO MULTIPLE SHUTDOWNS IN ORDER TO HAVE THE RECORDING TO BE STARTED BACK UP. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18445169 ↗MalfunctionDec 28, 2023Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch
THE AMBULATORY CARE CLINICAL MANAGER REPORTED THAT THE CAMERA AND APPLICATION FREEZES CAUSING DATA AND VIDEO LOSS IN EMU ROOM 3. THERE IS AN ERROR MESSAGE THAT APPEARS WHEN THIS HAPPENS. THEY HAVE TO DO MULTIPLE SHUTDOWNS IN ORDER TO HAVE THE RECORDING TO BE STARTED BACK UP. THEY LOST THE FIRST PORTION OF THE RECORDING WHICH STARTED FROM 10 AM THAT DAY AFTER THE PATIENT WAS CONNECTED TO EEG. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18407649 ↗MalfunctionDec 21, 2023Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch
THE EEG TECHNICIAN REPORTED THAT THEY HAD A CAMERA OUTAGE IN THEIR EMU ROOM 2 AT 2:30 AM ON 11/30/2023 AND THE RECORDING CAMERA WINDOW WAS BLACK ON BOTH THE MONITORING TECHNICIAN'S SIDE AND THE ACQUISITION MACHINE. THE EEG TECHNICIAN CLOSED OUT OF THEIR PROGRAM AND WATCHED THE PATIENT. THEY REBOOTED THE EMU ROOM 2 COMPUTER AND WAITED FOR IT TO FULLY LOAD, RESTARTED THE ACQUISITION TO MAKE SURE THEY WERE ABLE TO SEE THE VIDEO DURING ACQUISITION. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18378139 ↗MalfunctionNov 30, 2023No Audible Alarm; Alarm Not Visible; Protective Measures Problem; No Audible Alarm; Alarm Not Visible; Protective Measures Problem
THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243806 ↗MalfunctionNov 30, 2023No Audible Alarm; Alarm Not Visible; Protective Measures Problem; No Audible Alarm; Alarm Not Visible; Protective Measures Problem
THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242787 ↗MalfunctionNov 30, 2023No Audible Alarm; Alarm Not Visible; Protective Measures Problem; No Audible Alarm; Alarm Not Visible; Protective Measures Problem
THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18239127 ↗MalfunctionOct 13, 2022Overheating of Device; Smoking; Temperature Problem; Overheating of Device; Smoking; Temperature Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE POWERVAR UPS THAT WAS BEING USED WITH THE EEG-1260A SYSTEM SPARKED AND SMOKED. THIS WAS NOT IN PATIENT USE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 15602131 ↗InjuryFeb 14, 2022Unintended Collision; Structural Problem; Device Tipped Over; Unintended Movement; Unintended Collision; Structural Problem; Device Tipped Over; Unintended Movement
THE CUSTOMER REPORTED THAT THEIR STAFF BUMPED INTO THE EEG CARD, CAUSING THE CAMERA TO FALL OF THE POLE ONTO THEIR RADIOLOGY STAFF ANKLE. THE CAMERA STILL WORKS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME WHEN THIS OCCURRED.
Patient problems: Unspecified Tissue Injury
MAUDE report 13530221 ↗InjuryFeb 14, 2022Structural Problem; Structural Problem
THE CUSTOMER REPORTED THAT THEIR STAFF BUMPED INTO THE EEG CARD, CAUSING THE CAMERA TO FALL OF THE POLE ONTO THEIR RADIOLOGY STAFF ANKLE. THE CAMERA STILL WORKS AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME WHEN THIS OCCURRED.
Patient problems: Unspecified Tissue Injury
MAUDE report 13530220 ↗MalfunctionFeb 5, 2022Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT BACK IN 11/2021, IT WAS REPORTED TO THEM THAT THE IR (INFRA RED) ILLUMINATOR SPARKED AND GAVE OFF SOME SMOKE. THE SYSTEM WAS TURNED OFF IMMEDIATELY, AND THEY DETERMINED IT WAS THE IR ILLUMINATOR. THEY CONTINUED TO USE THE EEG SYSTEM WITHOUT USING THE ILLUMINATOR UNTIL NOW. HOWEVER, ONE OF THE DOCTORS NEEDS IT WORKING. THIS IS NOT AN ISSUE WITH THE EEG ITSELF BUT WITH THE THIRD PARTY IR ILLUMINATOR MANUFACTURED BY BOSCH. THIS DEVICE WAS NOT IN PATIENT USE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 13466880 ↗MalfunctionJul 24, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem
THE MONITOR TECHNICIAN REPORTED THAT THERE WAS A BURNING SMELL FROM THE SYSTEM. THEY DID SOME TROUBLESHOOTING AND FOUND THAT THE POWER SUPPLY INSIDE THE COMPUTER WAS CAUSING THE SMELL. THEY REPLACED THE PART WITH THE NIHON KOHDEN PROVIDED PART NUMBER FOR THE REPLACEMENT POWER SUPPLY. ISSUE WAS RESOLVED BY THE CUSTOMER. THIS WAS NOT IN PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12222736 ↗
Other Nihon Kohden Corporation products
All Nihon Kohden Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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