Alice 6 Alice 6, Base Station, LDx, INTLRecalls & reported problems
Respironics, Inc. · Alice 6, Base Station System, LDx, International · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959020702), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excessive Heating” (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
- Excessive Heating1
- Naturally Worn1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Naturally Worn; Excessive Heating; Naturally Worn; Excessive Heating
THIS REPORT IS BEING SUBMITTED TO INCLUDE THE PRODUCT UDI.
Patient problems: Burn(s)
MAUDE report 21127217 ↗
Other Standard polysomnograph with electroencephalograph devices
- Micromed SD LTM 64 PLUSMicromed SPA · Standard Polysomnograph With Electroencephalograph1 recall0 reports
- Alice 6 Alice 6 LDxS Headbox, NARespironics, Inc. · Standard polysomnograph with electroencephalograph2 reports
- Somnostar 16610Carefusion Corporation · Standard Polysomnograph With Electroencephalograph2 reports
- Alice 6 Alice 6, Base Station, LDx, NARespironics, 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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