Neurofax EEG-1200ARecalls & reported problems
Nihon Kohden Corporation · Neurofax Electroencephalograph · Class 2
All models of Neurofax (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nihon Kohden Neurofax EEG system records brain electrical activity. Reports mostly describe software crashes and freezes, lost video and recording data, and alarms or displays not working correctly during exams. FDA records include 25 reports that name its identifier, mentioning 2 deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04931921110904), received between Dec 6, 2017 and Jun 20, 2025 — classified as 2 deaths, 23 malfunctions.
The most frequently reported specific device problem is “Application Program 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem4
- Temperature Problem4
- Alarm Not Visible3
- Application Program Freezes or Fails to Launch3
- No Audible Alarm3
- Output Problem3
- Overheating of Device3
- Protective Measures Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient3
- Death2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionJul 24, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem
THE MONITOR TECHNICIAN REPORTED THERE WAS A BURNING SMELL COMING 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 12222735 ↗MalfunctionMar 25, 2021Power Problem; Power Problem
THE CUSTOMER REPORTED THAT THEIR COMPUTER TURNING OFF UNEXPECTEDLY DURING A SURGICAL CASE. THE CUSTOMER ALSO REPORTED THAT THEY WERE ABLE TO RECOVER WITH MINIMAL DATA LOSS AND CONTINUE RECORDING, BUT ONLY AFTER HAVING A TECH GO INTO THE ROOM AND TURN THE RECORDER BACK ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11572948 ↗MalfunctionMar 25, 2021Power Problem; Power Problem
THE CUSTOMER REPORTED THAT THEIR COMPUTER TURNING OFF UNEXPECTEDLY DURING A SURGICAL CASE. THE CUSTOMER ALSO REPORTED THAT THEY WERE ABLE TO RECOVER WITH MINIMAL DATA LOSS AND CONTINUE RECORDING, BUT ONLY AFTER HAVING A TECH GO INTO THE ROOM AND TURN THE RECORDER BACK ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11571856 ↗MalfunctionNov 2, 2020Application Program Problem; Output Problem; Application Program Problem; Output Problem
THE EEG REPORTED THAT THE PATIENT NAME ON THE LTM STUDY HAD CHANGED. THEY HAD STARTED THE STUDY AND WHEN THEY FINISHED RECORDING THERE WAS A DIFFERENT PATIENT NAME. IT IS UNCLEAR IF SOMEONE ACCIDENTALLY CHANGED THE NAME OR NOT. THEY ARE NOT SURE HOW THIS HAPPENED. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASSISTED IN CHANGING THE PATIENT INFORMATION. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10776084 ↗DeathMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT A PATIENT EXPIRED DURING AN EEG STUDY.
Patient problems: Death; Patient Problem/Medical Problem
MAUDE report 8460248 ↗MalfunctionJan 4, 2019Mechanical Problem; Mechanical Problem
THE EEG TECH REPORTED THAT THE CASTER ON CART FOR THE EEG SYSTEM CAME OFF. THEY STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED ANDCAUSED IT TO FALL OFF. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8220331 ↗MalfunctionDec 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THAT THE EEG DATA RECORDED UNDER ANOTHER PATIENT'S STUDY NODE. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8131035 ↗MalfunctionDec 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THAT THE EEG DATA RECORDED UNDER ANOTHER PATIENT'S STUDY NODE. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8131024 ↗MalfunctionNov 9, 2018Temperature Problem; Temperature Problem
THE EEG-1200A IS AN EEG SYSTEM. THE CUSTOMER CALLED REGARDING A SYSTEM THAT HAS NOT BEEN USED IN OVER A YEAR AND STATED THAT THEY JUST REPLACED THE CAMERA BUT THEY COULD NOT START THE EXAM. OUR TECHNICAL SUPPORT SPOKE WITH THE CUSTOMER AND FOUND THAT THE CAMERA WAS WORKING BUT THE CAMERA CAPTURE UNIT WAS OVERHEATING. THIS DEVICE IS AN ACCESSORY THAT IS REQUIRED FOR THE CAMERA TO WORK WITH THE EEG SYSTEM TO RECORD VIDEO. WE HAVE CONTACTED THE CUSTOMER FOR ADDITIONAL INFORMATION BUT HAVE NOT RECEIVED A RESPONSE FROM THEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8057834 ↗MalfunctionJun 13, 2018Smoking; Smoking
THE BIOMEDICAL ENGINEER REPORTED THAT THE UPS STARTED SMOKING DURING THE USE OF THE EEG-1200A.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7598830 ↗DeathMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED WHILE BEING CONNECTED TO OUR MACHINE.
Patient problems: Death
MAUDE report 7520252 ↗MalfunctionMay 10, 2018Device Stops Intermittently; Detachment of Device or Device Component; Device Stops Intermittently; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE KVM GCX ASSEMBLY USED WITH OUR ELECTROENCEPHALOGRAM EEG-1200A SYSTEM FELL ON A PATIENT. THIS WAS REPORTED TO US ON 09/21/2018 AND WAS INFORMED THAT THIS INCIDENT HAPPENED THIS PAST SPRING, WE HAVE CONTACTED THE CUSTOMER FOR ADDITIONAL PATIENT AND DEVICE INFORMATION BUT HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7503746 ↗MalfunctionMar 2, 2018Display or Visual Feedback Problem; Device Operates Differently Than Expected; Output Problem; Display or Visual Feedback Problem; Device Operates Differently Than Expected; Output Problem
THE EEG TECH REPORTED THAT THERE WAS A STORAGE RING BUFFER THAT OCCURRED, AND THE EEG-1200A HAD RECORDED A CORRUPT STUDY WHERE TWO SEGMENTS OF THE STUDY RECORDED OVERLAPPING EACH OTHER AFTER THE STORAGE RING BUFFER. ONE SEGMENT HAD THE PATIENT EVENT MARKED ON THE CORRECT TIME WITH VIDEO, AND THE OTHER RECORDED WITH THE PATIENT EVENT MARKED ON THE INCORRECT TIME WITH NO VIDEO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7311746 ↗MalfunctionDec 6, 2017Smoking; Smoking
THE EEG TECH REPORTED THE EEG / PSG COMBO SYSTEM "POPPED AND STARTED SMELLING LIKE SOMETHING WAS BURNT."
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7087049 ↗
Other Non-normalizing quantitative electroencephalograph software devices
- Neurofax EEG-1260ANihon Kohden Corporation · Non-normalizing quantitative electroencephalograph software4 reports
- CARESCAPE Monitor B850 CPU-C1GE Healthcare Finland Oy · Non-normalizing quantitative electroencephalograph software1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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