TrilogyRecalls & reported problems across all models
Respironics, Inc. · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
11 open recalls name at least one Trilogy model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 21,644
- Deaths reported
- 151
- Injuries reported
- 246
- Recalls
- 11
We found 46 models of Trilogy by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 21,644 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2015 and Sep 30, 2026 — classified as 151 deaths, 246 injuries, 21,232 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (3,384 reports).
11 FDA recall records name at least one of these models by its device identifier, 11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Trilogy recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0291-2025 · Root cause: Device Design · names 5 of these models · Recall details · FDA record ↗
- Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0290-2025 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
- Jul 16, 2024Open, Classified
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Z-2944-2024 · Root cause: Device Design · names 8 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1504-2024 · Root cause: Device Design · names 5 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1503-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1502-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Nov 27, 2023Open, Classified
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
Z-0638-2024 · Root cause: Device Design · names 8 of these models · Recall details · FDA record ↗
- May 1, 2023Open, Classified
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Z-1650-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- May 1, 2023Open, Classified
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Z-1649-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Z-1287-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Dec 7, 2022Open, Classified
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Z-0882-2023 · Root cause: Process design · Recall details · FDA record ↗
Most reported Trilogy problems
Device problems
- Circuit Failure3,384
- Battery Problem3,308
- Failure to Recalibrate2,611
- Failure to Charge2,442
- Device Displays Incorrect Message1,964
- Device Operational Issue1,475
- Mechanical Problem1,431
- No Display/Image1,380
Patient problems
- No Clinical Signs, Symptoms or Conditions12,458
- No Patient Involvement4,441
- No Consequences Or Impact To Patient4,222
- No Known Impact Or Consequence To Patient291
- Unspecified Respiratory Problem121
- Headache75
- Death74
- Dizziness66
Trilogy models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trilogy Trilogy100 Ventilator, United StatesVENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- 8 deaths2,493 reports
- Trilogy 00CONTINUOUS, VENTILATOR, HOME USE15 deaths2,059 reports
- Trilogy Trilogy O2 Ventilator JapanVENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- 2 deaths1,594 reports
- Trilogy Trilogy 202 Ventilator InternationalVENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- Trilogy Trilogy Evo Ventilator, IntlCONTINUOUS, VENTILATOR, HOME USE4 recalls3 deaths648 reports
- 696 reports
- Trilogy Trilogy 100 Ventilator, ChinaVENTILATOR, CONTINUOUS, FACILITY USE1 death447 reports
- Trilogy Trilogy Evo Ventilator with oxygen blending model, EUVENTILATOR, CONTINUOUS, FACILITY USE6 recalls16 reports
- 6 recalls9 reports
- 1 death304 reports
- 4 recalls94 reports
- Trilogy Trilogy200 Ventilator, United StatesCONTINUOUS, VENTILATOR, HOME USE4 deaths282 reports
- Trilogy IT2110X21BANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Trilogy Evo Ventilator, EUVENTILATOR, CONTINUOUS, FACILITY USE4 recalls69 reports
- Trilogy Trilogy Evo Ventilation system w/oxygen blending model, ITVENTILATOR, CONTINUOUS, FACILITY USE5 recalls0 reports
- 154 reports
- Trilogy 00CONTINUOUS, VENTILATOR, HOME USE1 death135 reports
- 129 reports
- Trilogy Trilogy 100 Ventilator, BrazilVENTILATOR, CONTINUOUS, FACILITY USE2 deaths127 reports
- Trilogy 00Oximeter4 deaths119 reports
- Trilogy Trilogy200 Ventilator, InternationalCONTINUOUS, VENTILATOR, HOME USE104 reports
- Trilogy Trilogy100 Ventilator, AustraliaVENTILATOR, CONTINUOUS, FACILITY USE97 reports
- 84 reports
- Trilogy 00CONTINUOUS, VENTILATOR, HOME USE63 reports
- Trilogy Trilogy 100 w/Bluetooth, U.S.AVENTILATOR, CONTINUOUS, FACILITY USE1 recall12 reports
- Trilogy 00VENTILATOR, CONTINUOUS, FACILITY USE46 reports
- Trilogy Trilogy200 Ventilator, Latin AmericaCONTINUOUS, VENTILATOR, HOME USE25 reports
- Trilogy Trilogy202 Ventilator, BrazilVENTILATOR, CONTINUOUS, FACILITY USE22 reports
- Trilogy Trilogy EC, U.S.AVENTILATOR, CONTINUOUS, FACILITY USE20 reports
- 15 reports
- Trilogy 00Oximeter15 reports
- Trilogy Trilogy202 Ventilator, KoreaVENTILATOR, CONTINUOUS, FACILITY USE14 reports
- Trilogy Trilogy 200 Ventilator, U.S.A.-RecertVENTILATOR, CONTINUOUS, FACILITY USE14 reports
- Trilogy U1054260BOximeter14 reports
- Trilogy Trilogy 202 Ventilator, U.S.A.-RENTALVENTILATOR, CONTINUOUS, FACILITY USE13 reports
- Trilogy Trilogy 200 Ventilator, U.S.A.-RentalVENTILATOR, CONTINUOUS, FACILITY USE9 reports
- TRILOGY TRILOGY 202 VENTILATOR, U.S.A-RECERTVENTILATOR, CONTINUOUS, FACILITY USE7 reports
- Trilogy R1054260BContinuous, ventilator, home use4 reports
- Trilogy 00VENTILATOR, CONTINUOUS, FACILITY USE3 reports
- Trilogy U1040005BContinuous, ventilator, home use3 reports
- 2 reports
- Trilogy RSL1054260BVentilator, continuous, facility use1 report
- Trilogy RTO1054260BOximeter1 report
Recent Trilogy adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
The manufacturer received information that a Trilogy Evo ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.On evaluation, a critical event code that indicates the power VBUS dropped was recorded in the event log; the system printed circuit board assembly was replaced. Preventative maintenance was completed. Cosmetic damage was reported and components replaced. The device passed final testing and was returned to the customer.Additional findings not related to the malfunction/issue: A non-critical event code was noted in the event log indicating replacement of the machine flow was sensor was required; the machine flow sensor was replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951504 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950685 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949245 ↗MalfunctionSep 30, 2026Failure to Power Up
A device was returned to a service center in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no harm or injury reported.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation. However, it was reported that the device failed to power on for evaluation and testing. It was reported the device was scrapped without further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949244 ↗MalfunctionSep 30, 2026Device Sensing Problem
A Trilogy EVO device was returned to a third-party service center for service. No medical intervention was specified. The device was not reported to be in clinical use.During the evaluation, the error log was downloaded and reviewed. An E0384 (EVT_PRESS_SENSOR_MISMATCH) error was identified. The air pathway was inspected for environmental debris and contamination; none was found. The evaluation did not identify a specific cause for the E0384 error. The device subsequently passed performance verification following service.Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event. Preventive maintenance components, including the particulate filter, inlet foam filter, and muffler, were replaced as part of the four-year service. A missing filter cover was also identified during external inspection and replaced.Should further investigation provide new information that impacts the outcome of the
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948383 ↗MalfunctionSep 30, 2026Mechanical Problem; Failure to Calibrate
A Trilogy 100 was returned to a third-party service center for service. There was no serious patient harm or injury that occurred or was reported. There was no allegation of device malfunction. The device was not reported to be in patient use.During the evaluation of the device at the third-party service center, the device failed a test step related to an active exhalation valve during testing. The device's active exhalation control module was replaced to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947050 ↗MalfunctionSep 30, 2026Failure to Power Up
The manufacturer received information that a Trilogy100 Ventilator, U.S.A. device had no power. There was no patient involvement, and no harm or injury reported.There were no visible foam particles in the device on evaluation. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the no power issue. The device was scrapped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946410 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem
The Trilogy 100 was returned to the third-party service center for evaluation. The device was not reported to be in clinical use, and no medical intervention was specified.During evaluation, the device error log was reviewed, and the following errors were identified:E009 ¿ Ventilator Inoperative / Motor Failure: This error indicates a motor blower failure. The motor blower requires replacement.E364 ¿ Internal Li-Ion Battery Fuse Open: This error indicates that the internal Li-Ion battery fuse is open. The internal battery is the final power source and requires replacement.The device also exceeded 30,000 blower hours and was due for 30,000-hour preventive maintenance. The air path kit was noted to be missing. Based on the evaluation findings, replacement of the motor blower and internal battery would be required to address the identified conditions. No parts were replaced because the device was scrapped at the customer's request.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944416 ↗MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940636 ↗MalfunctionSep 29, 2026Battery Problem
The manufacturer received information that a Trilogy 100 ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.During the device evaluation, a critical, high-priority ventilator service required error code 199- ERR_VLI_ION_FAILURE was noted in the device error log indicating a failure that affects the communication to the batteries and the selection of the power sources. No visible foam particles were noted in the device. No repair was completed on the device; the device was processed as scrap and discarded per local regulations.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934118 ↗MalfunctionSep 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923084 ↗MalfunctionSep 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923080 ↗MalfunctionSep 28, 2026Failure to Power Up
The manufacturer received information that a Trilogy 100 Ventilator device was returned to a third-party service center. There was no patient involvement and no allegation of serious or permanent harm or injury. During the evaluation, the service technician observed that the device had no power/did not turn on.Additionally, no visible foam particles were found. The evaluation did not identify any specific component malfunction that would need to be replaced to resolve the no-power issue. The device did not read the data; therefore, no access to information. The device was scrapped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922504 ↗MalfunctionSep 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921553 ↗MalfunctionSep 28, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921548 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
- Philips DreamStation190 models · 32,422 reports
- Trilogy Evo20 models · 5,473 reports · 12 recalls
- Trilogy 1008 models · 5,088 reports
- BiPAP System One 60 Series40 models · 4,599 reports
- BiPAP A4037 models · 1,606 reports · 3 recalls
- BiPAP autoSV Advanced System One 60 Series19 models · 1,166 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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