Alice PDx Alice PDx Sleep Diagnostic System, BRRecalls & reported problems
Respironics, Inc. · Alice PDx Portable Sleep Diagnostic System, Brazil · 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 00606959038820), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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
- Overheating of Device1
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 15, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT ALLEGING BURNING OF THE PLATE, AN ISSUE WITH "THE CARD," AND THE DEVICE NOT STAYING ON AS INTENDED. THIS REPORT IS RELATED TO AN ALICE PDX DEVICE. NO DEATH, SERIOUS HARM OR INJURY WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23306596 ↗
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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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