Natus 013926Recalls & reported problems
Xltek · Natus Quantum Base Unit · Class 2
All models of Natus (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382830016315), received between Mar 21, 2024 and Sep 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (1 report).
1 other recall cover devices cleared under the same FDA submission (K143440); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Circuit Failure1
- Device Emits Odor1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143440. One submission often covers many models, so check the product and lot details in each record.
- Z-0581-2016 · Nov 11, 2015 · TerminatedNatus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display,
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-03-8001-INTSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Seer Home SM-01-8001Seer 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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