Alice 6 Alice 6, Base Station, LDx, NARecalls & reported problems
Respironics, Inc. · Alice 6, Base Station System, LDx, North America · 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 00606959004207), received between Oct 29, 2025 and Oct 29, 2025 — classified as 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Circuit Failure; Circuit Failure
THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO A ALICE 6, BASE STATION SYSTEM, NO ALLEGATION REPORTED BY THE PATIENT. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING EVALUATION IT WAS OBSERVED THE SBC WITH ELECTRICAL DAMAGE AND ADDITIONAL FAILURES OBSERVED HARD DISK FRONT, RIGHT LEFT COVER WITH PHYSICAL DAMAGE. THERE WAS ONE ERROR HAS BEEN IDENTIFIED AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413597 ↗
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, 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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