Neurofax EEG-1260ARecalls & 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04931921009161), received between Feb 14, 2022 and Sep 16, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Smoking” (2 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
- Smoking2
- Structural Problem2
- Device Tipped Over1
- Output Problem1
- Overheating of Device1
- Temperature Problem1
- Unintended Collision1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗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 ↗
Other Non-normalizing quantitative electroencephalograph software devices
- Neurofax EEG-1200ANihon Kohden Corporation · Non-normalizing quantitative electroencephalograph software2 deaths25 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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