Natus 006562Recalls & reported problems
Xltek · EMU40EX Breakout Box · 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 00382830011297), received between May 14, 2022 and Sep 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (1 report).
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
- Intermittent Shock/Stimulation1
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: 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 ↗MalfunctionMay 14, 2022Intermittent Shock/Stimulation; Intermittent Shock/Stimulation
EMU40EX BREAKOUT BOX-REFURB - THE CUSTOMER REPORTS THAT WHEN CONNECTED TO A PATIENT WITH ELECTRODES, SOME SHOCKS ARE BEING SENT TO THE PATIENT VIA FP1 AND FP2. THEY USED THE SAME HEADBOX ON A DIFFERENT PATIENT AND THE SHOCKING STILL HAPPENED. NO MEDICAL ATTENTION WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14402884 ↗
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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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