BiliLux Phototherapy Light MU20100Recalls & reported problems
Draeger Medical Systems, Inc. · BiliLux LED Phototherapy System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049098094900), received between Jan 22, 2024 and Jul 30, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Detachment of Device or Device Component2
- Device Tipped Over1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE BILILUX DETACHED FROM THE CONNECTION TO THE ARTICULATING ARM. ACCORDING TO THE CLINICIAN IT DID FALL ONTO THE INFANT, AND THAT THE INFANT WAS NOT HARMED. NO ADVERSE PATIENT IMPACT OR DEATH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19861241 ↗MalfunctionMar 8, 2024Device Tipped Over; Device Tipped Over
A CUSTOMER REPORTED THAT A BILILUX SPRING ARM SLOWLY COLLAPSED ONTO PEDIATRIC PATIENT. NO DEATH WAS REPORTED, AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY. IT WAS DETERMINED THAT THE SWING ARM BOLT HAD COME LOOSE OVER TIME AND REQUIRED TIGHTENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18866231 ↗MalfunctionJan 23, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PHOTO THERAPY LAMP WAS DISLODGED FROM ITS STAND AND FELL INTO THE PATIENT COMPARTMENT. IT WAS CONFIRMED BY THE USER THAT THE REPORTED INCIDENT DID NOT RESULT IN ANY HEALTH CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18560856 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PHOTO THERAPY LAMP WAS DISLODGED FROM ITS STAND AND FELL INTO THE PATIENT COMPARTMENT. IT WAS CONFIRMED BY THE USER THAT THE REPORTED INCIDENT DID NOT RESULT IN ANY HEALTH CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552796 ↗
Other Unit, Neonatal Phototherapy devices
- neoBLUE LED Phototherapy SystemNatus Medical Incorporated · Unit, Neonatal Phototherapy2 reports
- neoBLUE CozyNatus Medical Incorporated · Unit, Neonatal Phototherapy1 report
- neoBLUE blanket Large Pad KitNatus Medical Incorporated · Unit, Neonatal Phototherapy1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page