NatusRecalls & reported problems across all models
Xltek · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Natus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 13 models of Natus by Xltek in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2021 and Sep 24, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Sparking” (4 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Natus recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 7, 2025Open, Classified
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Z-1925-2025 · Root cause: Employee error · Recall details · FDA record ↗
Most reported Natus problems
Device problems
- Sparking4
- Loss of Data3
- Circuit Failure2
- Device Emits Odor2
- Electrostatic Discharge2
- Material Frayed2
- No Display/Image2
- Battery Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Blister1
- Skin Tears1
Natus models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Natus OBM00002Amplitude-Integrated Electroencephalograph1 recall3 reports
- Natus 008043Full-Montage Standard Electroencephalograph5 reports
- Natus 003555Stimulator, Photic, Evoked Response3 reports
- Natus 10388Automatic Event Detection Software For Full-Montage Electroencephalograph2 reports
- Natus 006562Full-Montage Standard Electroencephalograph2 reports
- Natus 013926Full-Montage Standard Electroencephalograph2 reports
- Natus 016862Full-Montage Standard Electroencephalograph2 reports
- Natus 61-000300Camera, Ophthalmic, Ac-Powered2 reports
- Natus OBM00401Reduced- Montage Standard Electroencephalograph1 report
- Natus 046621Reduced- Montage Standard Electroencephalograph1 report
- Natus 022419Amplitude-Integrated Electroencephalograph1 report
- Natus 021911Full-Montage Standard Electroencephalograph1 report
- Natus 016867Full-Montage Standard Electroencephalograph1 report
Recent Natus adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 13, 2026Fire
POWER CORD/PLUG FROM THE UPS CAUGHT FIRE. IT HAS SCORCH MARKS AND MELTING AROUND THE CORD. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157951 ↗MalfunctionSep 2, 2025Circuit Failure; Device Emits Odor; Circuit Failure; Device Emits Odor
PART: 006562R, EMU40EX BREAKOUT BOX-REFURB - SMOKE WAS EMITTED FROM TWO BASE UNITS IN CONNECTION WITH THIS BREAKOUT BOX. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS VIDEO-EEG. THE SMOKE AND ODOR APPEARED IMMEDIATELY AFTER STARTING THE REGISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930282 ↗MalfunctionSep 2, 2025Circuit Failure; Device Emits Odor; Circuit Failure; Device Emits Odor
PART: 013926R, QUANTUM BASE UNIT REFURB - SMOKE EMITTED FROM BASE UNIT WHEN CONNECTED TO THEIR EMU40EX BREAKOUT BOX. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS VIDEO-EEG. THE SMOKE AND ODOR APPEARED IMMEDIATELY AFTER STARTING THE REGISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22930218 ↗MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information; Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Information
AMPLIFIER, BRAINWATCH AND PERSYST ANALYZER -FAULTY SEIZURE DETECTIONS. THE CUSTOMER INDICATES FALSE SEIZURE BURDEN DETECTIONS ON STUDY (FALSE POSITIVE). FEEDBACK FROM THE CUSTOMER: IN ONE STUDY, THE BRAIWATCH SYSTEM CONCLUDED THAT THE PATIENT WAS HAVING A SEIZURE. THE HEATHCARE TEAM TREATED THE PATIENT FOR SEIZURE. LATER ON, WHILE NEUROLOGIST REVIEWED EEG STUDY, HE DETERMINED THAT IT'S ALL ARTIFACT AND NOT SEIZURE. IT WAS CONFIRMED BY RERUNNING THE STUDY IN CONVENTIONAL EEG SYSTEM (MODEL UNKNOWN) THAT PATIENT HAD NOT HAD A SEIZURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530125 ↗MalfunctionJan 17, 2025Sharp Edges; Sharp Edges
NATUS PHOTIC STIM KIT - EEG TECH WAS ADJUSTING LIGHT WHEN HER SKIN GOT PINCHED BETWEEN THE TWO ARMS OF EQUIPMENT. 30 MINUTES IN THE ED GETTING FINGER STITCHED UP.
Patient problems: Skin Tears
MAUDE report 21177743 ↗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 ↗MalfunctionMar 21, 2024Sparking; Sparking
QUANTUM BASE UNIT REFURB - USB CONNECTION SPARKING. PLUGGED USB FROM PC TO QUANTUM BASE UNIT AND CONNECTION SPARKS. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18956213 ↗MalfunctionJan 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) MISLABELED. THE CUSTOMER REPORTED EXPERIENCING ISSUES WITH THEIR OBM (OLYMPIC BRAINS MONITOR) HAVING THE ELECTRODE PLACEMENT STICKER ON BACKWARDS, RESULTING IN THE ELECTRODES BEING APPLIED INCORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490690 ↗MalfunctionAug 18, 2023Computer Software Problem; Computer Software Problem
PART LC200-9 SLEEP WORKS 9.X ACQUISITION SOFTWARE WITHOUT SPIKE: CUSTOMER STATES THAT REPORTS ARE SHOWING INCORRECT COUNT FOR CENTRAL APNEA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17573905 ↗MalfunctionJul 13, 2023Electrostatic Discharge; Electrostatic Discharge
PART 021911 NATUS BRAIN MONITOR BREAKOUT - 2 PATIENTS SAID THEY COULD FEEL SOMETHING WHEN THE ELECTRODES WERE APPLIED AND THE STUDY WAS RUNNING. THE FIRST PATIENT DESCRIBED THE FEELING AS BEING COLD, THE SECOND PATIENT DESCRIBED IT AS STATIC FEELING SHE COULD FEEL ALL OVER HER BODY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314509 ↗MalfunctionJul 13, 2023Electrostatic Discharge; Electrostatic Discharge
PART 016862R NATUS QUANTUM II BASE UNIT REFURBISHED - 2 PATIENTS SAID THEY COULD FEEL SOMETHING WHEN THE ELECTRODES WERE APPLIED AND THE STUDY WAS RUNNING. THE FIRST PATIENT DESCRIBED THE FEELING AS BEING COLD, THE SECOND PATIENT DESCRIBED IT AS STATIC FEELING SHE COULD FEEL ALL OVER HER BODY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314466 ↗MalfunctionJun 12, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) - OBM DAB (DIGITAL ACQUISITION BOX) - THE CUSTOMER REPORTED A SIGNAL, "FAILED SELF CHECK." PER QUESTIONNAIRE, THE MEDICAL TEAM WERE WORKING WITH A BABY WHEN THE OBM SIGNALED "FAILED SELF CHECK" FOR 20 -30 MINUTES. THE REGISTERED NURSE TRIED TO TROUBLESHOOT, INCLUDING CHANGING TO A DIFFERENT USB. THE OBM UNIT FINALLY WORKED AFTER 7-8 ATTEMPTS BUT THEY WERE UNCLEAR WHAT MADE THE DIFFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17112782 ↗
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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