Alice 6 Alice 6 LDxS Headbox, NARecalls & reported problems
Respironics, Inc. · Alice 6 Polysomnography System LDxS Sensor Headbox, North America · Class 2
Data updated Oct 18, 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 00606959004214), received between Apr 23, 2024 and Jun 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Degraded” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded1
- Unintended Electrical Shock1
Patient problems
- Dizziness1
- Eye Irritation1
- Headache1
- Nausea1
- No Clinical Signs, Symptoms or Conditions1
- Skin Inflammation/ Irritation1
- Unspecified Respiratory Problem1
- Vomiting1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2024Degraded; Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, NAUSEA / VOMITING. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Dizziness; Eye Irritation; Headache; Nausea; Skin Inflammation/ Irritation; Unspecified Respiratory Problem; Vomiting
MAUDE report 19612189 ↗MalfunctionApr 23, 2024Unintended Electrical Shock; Unintended Electrical Shock
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE A CUSTOMER WAS PLUGGING IN AN ALICE 6 HEAD BOX, THEY RECEIVED A SHOCK. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169162 ↗
Other Standard polysomnograph with electroencephalograph devices
- Micromed SD LTM 64 PLUSMicromed SPA · Standard Polysomnograph With Electroencephalograph1 recall0 reports
- Somnostar 16610Carefusion Corporation · Standard Polysomnograph With Electroencephalograph2 reports
- Alice 6 Alice 6, Base Station, LDx, NARespironics, Inc. · Standard polysomnograph with electroencephalograph1 report
- Alice 6 Alice 6, Base Station, LDx, INTLRespironics, Inc. · Standard polysomnograph with electroencephalograph1 report
- Somnostar 28483-001Carefusion Corporation · Standard Polysomnograph With Electroencephalograph1 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.
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