System OneRecalls & reported problems across all models

We found 4 models of System One by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2017 and Feb 18, 2026 — classified as 6 deaths, 45 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Degraded” (64 reports).

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

Most reported System One problems

System One models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• System One System One Heated Humidifier, US

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  4 deaths49 reports
• System One System One Heated Tube Humidifier, US

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  1 death10 reports
• System One System One Heated Humidifier, INTL

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  1 death6 reports
• System One System One REMstar Heated Humidifier, INTL

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  4 reports

Recent System One adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE THIRTY-TWO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDED THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374894 ↗
• MalfunctionFeb 16, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE 12 ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDED THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342474 ↗
• MalfunctionFeb 13, 2026Degraded

  A DEVICE WAS RETURNED TO THIRD-PARTY 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329899 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER SERVICE CENTER. THERE WAS THIRTEEN ERROR CODES FOUND. THE MANUFACTURER SERVICE CENTER CONCLUDES THAT THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670467 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER 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. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER SERVICE CENTRE. THERE WAS 32 ERROR CODES FOUND. THE MANUFACTURER SERVICE CENTRE CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670447 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER'S SERVICE CENTERR IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM. DURING THE EVALUATION, THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER'S SERVICE CENTER. THERE WAS 32 ERROR CODES FOUND. THE MANUFACTURER'S SERVICE CENTER CONCLUDES THAT THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670256 ↗
• MalfunctionNov 28, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A MANUFACTURER'S 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. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM. DURING THE EVALUATION, THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER'S SERVICE CENTER. THERE WERE 32 ERROR CODES FOUND. THE MANUFACTURER'S SERVICE CENTER CONCLUDES THAT THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23670199 ↗
• DeathOct 28, 2025Contamination; Contamination

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGING KIDNEY DISEASE/TOXICITY, DEATH, HEART FAILURE AND LUNG FAILURE. THERE WAS REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED A BLACK SUBSTANCE, CONSISTENT WITH SOUND ABATEMENT FOAM DEGRADATION, WAS OBSERVED ON THE OUTSIDE BOTTOM OF THE BLOWER BOX AND WAS STUCK TO IT. PRODUCT INVESTIGATION LABORATORY WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. NINE ERRORS WERE LOGGED. DUST LIKE CONTAMINATION AT THE AIR INLET, ON THE PCA, IN THE BLOWER BOX AND THROUGHOUT THE INSIDE ENCLOSURE. PRODUCT INVESTIGATION LABORATORY CAN CONFIRM THE PRESENCE OF MULTIPLE CONTAMINANTS THAT ARE NOT CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM FROM THE SECONDARY FINDINGS. PROD

  Patient problems: Heart Failure/Congestive Heart Failure; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 23402599 ↗
• InjuryOct 28, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SYSTEM ONE DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGES KIDNEY DISEASE/TOXICITY AND LUNG DISEASE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 23400426 ↗
• InjuryOct 23, 2025Contamination; Contamination

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING NOSE IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY, KIDNEY DISEASE/TOXICITY AND LIVER DISEASE/TOXICITY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER-INITIATED THERAPY WITH THE DEVICE AND VERIFIED AIRFLOW, USING A KNOWN GOOD MANUFACTURER SUPPLIED POWER SUPPLY AND AC POWER CORD. PIL ALSO OBSERVED CUSTOMERS HUMIDIFIER HEATER PLATE DID HEAT. THE MANUFACTURER OBSERVED THE FOLLOWING SOUND ABATEMENT DEGRADED FOAM INDICATIONS: BLACK SUBSTANCE, CONSISTENT WITH SOUND ABATEMENT FOAM DEGRADATION, WAS OBSERVED ON THE OUTSIDE BOTTOM OF THE BLOWER BOX AND WAS STUCK TO IT. BLACK PIECES OF A BLACK SUBSTANCE, CONSISTENT WITH SOUND ABATEMENT FOAM DEGRADATION, WERE FOUND ON THE BOTTOM OF THE ENCLOSURE. THE MANUFACTURER WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. SECONDARY FINDINGS: DUST-LIKE CONTAMINA

  Patient problems: Headache; Hypersensitivity/Allergic reaction; Unspecified Hepatic or Biliary Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 23367128 ↗
• InjuryOct 23, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING CANCER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Cancer

  MAUDE report 23365710 ↗
• InjuryJan 17, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING CANCER AND ESOPHAGUS CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Cancer

  MAUDE report 21181747 ↗
• InjuryNov 25, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING ASTHMA, CANCER WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma; Cancer

  MAUDE report 20773452 ↗
• MalfunctionNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE SYSTEM ONE HTD HUMID ASSY DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING NOSE IRRITATION, SKIN IRRITATION. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Respiratory Problem

  MAUDE report 20650151 ↗
• InjuryNov 1, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP/ BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING RESPIRATORY FAILURE . NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20585461 ↗

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