BiPAPRecalls & reported problems across all models

We found 2 models of BiPAP by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Oct 28, 2024 and Oct 27, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

BiPAP 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.

1. May 9, 2025Open, Classified

   This device does not indicate for use in patients with respiratory failure.

   Z-2037-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 26, 2024Open, Classified

   Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

   Z-1813-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported BiPAP problems

BiPAP models

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

• BiPAP SPX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls5 reports
• BiPAP BiPAP A30 EFL, DE

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports

Recent BiPAP adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION OF THE ALLEGED ISSUE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393450 ↗
• MalfunctionMay 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "FAN NOT OPERATIONAL" CONDITION HAD OCCURRED ON A BIPAP A40 PRO DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090249 ↗
• MalfunctionFeb 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399629 ↗
• MalfunctionFeb 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER; HOWEVER, EVALUATION HAS NOT YET BEGUN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397128 ↗
• MalfunctionOct 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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544582 ↗

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
• Trilogy46 models · 21,644 reports · 11 recalls
• 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