Trilogy Trilogy200 Ventilator, InternationalRecalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00606959022683), received between Sep 30, 2015 and Apr 29, 2026 — classified as 103 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (17 reports).

5 other recalls cover devices cleared under the same FDA submission (K093416); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Computer Software Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038484 ↗
• MalfunctionApr 29, 2026Computer Software Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036026 ↗
• MalfunctionApr 29, 2026Display or Visual Feedback Problem

  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 REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO THE LCD SCREEN. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034427 ↗
• MalfunctionApr 28, 2026Computer Software Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021755 ↗
• MalfunctionApr 23, 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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE THE DEVICE FAILED TO POWER ON AND WAS INOPERABLE. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973394 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913445 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913437 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913434 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911170 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW AND PRESSURE VERIFICATION WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911169 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911168 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911167 ↗
• MalfunctionApr 17, 2026Device Sensing Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911165 ↗
• MalfunctionApr 10, 2026Calibration Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO THE INTERNAL LITHIUM-ION BATTERY CHARGE CAPACITY WAS IDENTIFIED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844483 ↗
• MalfunctionApr 3, 2026Electrical /Electronic Property Problem; Power Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO THE INTERNAL LITHIUM-ION BATTERY CHARGE CAPACITY WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780645 ↗
• MalfunctionApr 3, 2026Calibration Problem

  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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO PRESSURE . THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779167 ↗
• MalfunctionApr 3, 2026Calibration Problem

  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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO MOTOR TEMPERATURE. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779166 ↗
• MalfunctionApr 3, 2026Calibration Problem

  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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATED TO POS FLOW. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779160 ↗
• MalfunctionMar 31, 2026Electrical /Electronic Property Problem; Power Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE, AN ERROR CODE RELATED TO DEVICE FAILURE AT HW POWER FAIL: RED LED FLASHING AND ALARM. THE DEVICE ONLY CAME IN FOR REMEDIATION; THEREFORE, NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738008 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem; Battery Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO THE POWER SOURCE WAS IDENTIFIED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701995 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem; Battery Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO FAILURE OF THE INTERNAL BATTERY TO CHARGE WAS IDENTIFIED. THE INTERNAL BATTERY WAS REPLACED AND THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699831 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem

  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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO THE VENTILATOR IS NOT OPERATIVE. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699828 ↗
• MalfunctionMar 10, 2026Degraded

  THE DEVICE WAS EVALUATED 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 IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY 200 VENTILATOR, INTERNATIONAL DEVICE, AT A THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE FOAM WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE'S OPERATING SOFTWARE WAS UPGRADED AND THE DEVICE PASSED FINAL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563601 ↗
• MalfunctionMar 10, 2026Degraded

  THE MANUFACTURER RECEIVED INFORMATION A TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS EVALUATED AT THE MANUFACTURER'S SERVICE CENTER WHERE FOAM PARTICLES WERE CONFIRMED INSIDE THE DEVICE ASSEMBLY. THE ISSUE WAS CORRECTED WITH REPLACEMENT OF THE TRILOGY INLET AIR PATH REMOVABLE FOAM. THE DEVICE PASSED FINAL TESTING AFTER REMEDIATION. THE DEVICE WILL BE INCLUDED IN FSCA 2021-05-A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556460 ↗
• MalfunctionMar 9, 2026Degraded; No Apparent Adverse Event

  THE DEVICE WAS EVALUATED 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 IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY 200 VENTILATOR, INTERNATIONAL DEVICE, AT A THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE BLOWER FOAM WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE'S OPERATING SOFTWARE WAS UPGRADED AND THE DEVICE PASSED FINAL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093416. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
• Z-1956-2021 · Jun 14, 2021 · Open, Classified
  Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
• Z-1065-2016 · Jan 18, 2016 · Terminated
  Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory su
• Z-1143-2014 · Feb 11, 2014 · Terminated
  Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilog
• Z-2024-2012 · Apr 27, 2012 · Terminated
  Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require m