Natus 008043Recalls & reported problems
Xltek · TrexHD Head Box · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382830015639), received between May 5, 2023 and Sep 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Loss of Data” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Data2
- Battery Problem1
- Data Problem1
- Electromagnetic Interference1
- Failure to Back-Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880713 ↗MalfunctionJun 8, 2026Failure to Back-Up; Data Problem
TREX HD HEADBOX-REFURB - 24-HOUR AMBULATORY EEG [ELECTROENCEPHALOGRAM] TEST RETURNED FOR DISCONNECT AND ONLY 3 MINUTES OF DATA ABLE TO BE UPLOADED. IT WAS CONFIRMED THE BOX MALFUNCTIONED AND ONLY 3 OF THE 24 HOURS OF DATA RECORDED. BOX TAKEN OUT OF SERVICE AND BMDI [BEDSIDE MEDICAL DEVICE INTERFACE] TICKET PLACED. THIS IS THE SECOND INCIDENT IN 2 WEEKS IN WHICH AN AMBULATORY EEG PATIENT RETURNED WITH EQUIPMENT ISSUES RESULTING IS DATA NOT ACQUIRED. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25426647 ↗MalfunctionMar 22, 2024Loss of Data; Loss of Data
NATUS RECEIVED A USER INCIDENT REPORT CONCERNING OUR PRODUCT - TREX HD HEADBOX - REPORT OF "MULTIPLE INSTANCES OF RECORDING DATA LOST DURING THE DEVICE USE. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18960142 ↗MalfunctionMar 22, 2024Loss of Data; Loss of Data
NATUS RECEIVED A USER INCIDENT REPORT CONCERNING OUR PRODUCT - TREX HD HEADBOX - REPORT OF "MULTIPLE INSTANCES OF RECORDING DATA LOST DURING THE DEVICE USE. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18960095 ↗MalfunctionMay 5, 2023Electromagnetic Interference; Electromagnetic Interference
PATIENT FELT THE A-EEG EQUIPMENT MAY HAVE BEEN FREQUENTLY BUT NOT CONSTANTLY INTERFERING WITH HIS PM-DEFIBRILLATOR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874683 ↗
Other Full-Montage Standard Electroencephalograph devices
- NA OPM660Medtronic Xomed, Inc. · Full-montage Standard Electroencephalograph101 reports
- NIM-ECLIPSE® ECLCMedtronic Xomed, Inc. · Full-montage Standard Electroencephalograph53 reports
- Seer Home SM-01-8001Seer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Seer Home SM-03-8001-INTSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Seer Home Monitoring PortalSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Sedline® Seditation Monitor 9513Masimo Corporation · Full-montage Standard Electroencephalograph38 reports
- NA DAQ916Medtronic Xomed, Inc. · Full-montage Standard Electroencephalograph27 reports
- SedLine™ EEG Sensor 2479Masimo Corporation · Full-montage Standard Electroencephalograph14 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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