Natus 003555Recalls & reported problems
Xltek · Natus Photic Stim Kit · Class 2
All models of Natus (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830015790), received between Feb 16, 2022 and Jan 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed2
- Sparking2
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Skin Tears1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionApr 6, 2022Material Frayed; Sparking; Material Frayed; Sparking
PART 003555 - NATUS PHOTIC STIM KIT PHOTIC POWER CABLE IS BROKEN. CUSTOMER REPORTED THEY "HEARD AND SAW SPARKING ON PART OF THE PHOTIC STIMULATOR'S POWER CORD." THE CUSTOMER STATED WHEN THEY WITNESSED THE SPARKING/ELECTRICAL DISCHARGE, THE ELECTRICAL POWER CORD WAS FRAY AND THE INTERNAL METAL WIRES WERE EXPOSED AT THE ELECTRICAL DISCHARGE'S LOCATION. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14019522 ↗MalfunctionFeb 16, 2022Material Frayed; Sparking; Material Frayed; Sparking
PART 003555 - NATUS PHOTIC STIM KIT - POWER CORD FRAYED / SPARKING / NOT WORKING. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13541559 ↗
Other Stimulator, Photic, Evoked Response devices
All Stimulator, Photic, Evoked Response devices →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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