OmniLab Advanced Plus OmniLab Advanced Plus, INTLRecalls & reported problems
Respironics, Inc. · OmniLab Advanced Plus, International · Class 2
All models of OmniLab Advanced Plus (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959029415), received between Mar 23, 2022 and Feb 29, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Aug 26, 2022Class IOpen, Classified
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1658-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Electrical /Electronic Property Problem2
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 29, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE DEVICES PCA AND BOTTOM ENCLOSURE WERE REPLACED AND THE FIRMWARE UPDATED TO V3.7. THE DEVICE PASSES TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18810999 ↗MalfunctionFeb 28, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MAIN PCA AND BLOWER ASSEMBLY WERE REPLACED TO RESOLVE THE REPORTED PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797604 ↗MalfunctionMar 23, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND NOISY BLOWER; BOTTOM ENCLOSURE, RIGHT SIDE ASSY, TOP ENCLOSURE DAMAGED BY UNKNOWN LIQUID AND DAMAGED INLET FOAM WERE OBSERVED DURING DEVICE EVALUATION. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869774 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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