BiPAP A30Recalls & reported problems across all models
Respironics, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one BiPAP A30 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 287
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls
- 3
We found 20 models of BiPAP A30 by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 287 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2017 and Sep 29, 2026 — classified as 1 death, 5 injuries, 281 malfunctions.
The most frequently reported specific device problem is “Degraded” (209 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
BiPAP A30 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.
- May 9, 2025Open, Classified
This device does not indicate for use in patients with respiratory failure.
Z-2036-2025 · Root cause: Device Design · names 13 of these models · Recall details · FDA record ↗
- 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-1814-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 26, 2022Open, Classified
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Z-1654-2022 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
Most reported BiPAP A30 problems
Device problems
- Degraded209
- Electrical /Electronic Property Problem68
- Circuit Failure25
- Adverse Event Without Identified Device or Use Problem7
- Device Sensing Problem3
- Overheating of Device3
- Unexpected Shutdown3
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions279
- Cough2
- Headache2
- Unspecified Kidney or Urinary Problem2
- Cancer1
- Cramp(s) /Muscle Spasm(s)1
- Death1
- Dyspnea1
BiPAP A30 models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BiPAP A30 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 recalls29 reports
- BiPAP A30 BiPAP A30 Ventilator, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 recalls1 death17 reports
- BiPAP A30 BiPAP A30 Ventilator, FRVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall52 reports
- BiPAP A30 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING97 reports
- BiPAP A30 BiPAP A30 Silver Series Ventilator, DEVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall28 reports
- BiPAP A30 BiPAP A30-S Silver Series VentilatorVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall18 reports
- BiPAP A30 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall18 reports
- BiPAP A30 BiPAP A30 Ventilator Private Label, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall13 reports
- BiPAP A30 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall4 reports
- BiPAP A30 BiPAP A30 Ventilator w/H Tube Humid, CAVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall3 reports
- BiPAP A30 BiPAP A30 Ventilator, AUVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall0 reports
- BiPAP A30 BiPAP A30 Ventilator, CAVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall0 reports
- BiPAP A30 BiPAP SOH VentilatorVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall0 reports
- BiPAP A30 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 recall0 reports
- BiPAP A30 BiPAP A30 Linde EOLUS 30Ventilator, continuous, non-life-supporting1 recall0 reports
- BiPAP A30 00Ventilator, continuous, non-life-supporting1 recall0 reports
- BiPAP A30 BiPAP A30 Vitalaire Vitalvent 30Ventilator, continuous, non-life-supporting1 recall0 reports
- BiPAP A30 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING5 reports
- BiPAP A30 BiPAP A30 Ventilator, CNVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 reports
- BiPAP A30 BiPAP A30 Ventilator, BRVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
Recent BiPAP A30 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938447 ↗MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938439 ↗MalfunctionSep 15, 2026Electrical /Electronic Property Problem
A Bipap A30 device was returned to a third-party service center for service. There was no serious patient harm or injury that occurred or was reported.During the evaluation at the third-party service center, a ventilator inoperative error code was found in the device's error log stating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. There is no documentation stated on a root cause and/or any component replacement to resolve the issue.No repairs were performed. The device will be scrapped per the customer's request.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775302 ↗MalfunctionSep 14, 2026Circuit Failure; Degraded; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762102 ↗MalfunctionSep 10, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713932 ↗MalfunctionAug 5, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145809 ↗MalfunctionAug 4, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133310 ↗MalfunctionJul 3, 2026Degraded
A BIPAP A30 DEVICE WAS RETURNED TO A 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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. THE DEVICE'S SOUND ABATEMENT FOAM WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, DUST FAIL CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25704669 ↗MalfunctionMay 11, 2026Circuit Failure; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THERE WERE TWO VENTILATOR INOPERATIVE ERROR CODES FOUND ON A BIPAP A30 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE THIRD-PARTY SERVICE TECHNICIAN OBSERVED THE ERROR CODE, CPU CANNOT COMMUNICATE WITH THE FLOW SENSOR USING I2C BUS AND CPU CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS, IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD HAD CAUSED THE ERROR CODES TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S PCA BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THE DEVICE WAS SCRAPPED PER THE CUSTOMER REQUEST. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A SUPPLEMENTAL REPORT WILL BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135299 ↗MalfunctionApr 1, 2026Degraded
A BIPAP A30 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST/DIRT/TOBACCO CONTAMINATION AND MISSING RUBBER FEET. THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES, AND THE PRINTED CIRCUIT ASSEMBLY (PCA) WILL NEED TO BE REPLACED. THESE ERROR CODES WERE 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 THE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WILL BE SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758020 ↗MalfunctionMar 30, 2026Electrical /Electronic Property Problem
A BIPAP A30 DEVICE WAS RETURNED TO A 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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. A ¿VENTILATOR INOPERATIVE¿ ERROR CODE WAS OBSERVED (E-20), INDICATING DEFECTIVE EEPROM. THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA); HOWEVER, THE AVAILABLE DOCUMENTATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. THE TECHNICIAN ALSO IDENTIFIED ERROR CODE E-96, INDICATING "UNABLE TO WRITE TO EVENT LOG." AS A RESULT OF E-96, THE TECHNICIAN RECOMMENDED REPLACING THE PCA. 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. THE SERVICE TECHNICIAN ALSO NOTED DUST/DIRT AND T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24732534 ↗MalfunctionMar 30, 2026Circuit Failure; Electrical /Electronic Property Problem
A BIPAP A30 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, VENTILATOR INOPERATIVE ERROR CODE INDICATING A FAILURE OF THE OUTLET PRESSURE SENSOR WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE. NO FINAL TESTING WAS DOCUMENTED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729908 ↗MalfunctionMar 30, 2026Electrical /Electronic Property Problem
A BIPAP A30 DEVICE WAS RETURNED TO A 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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. A ¿VENTILATOR INOPERATIVE¿ ERROR WAS OBSERVED (E-20), INDICATING DEFECTIVE EEPROM. THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA); HOWEVER, THE AVAILABLE DOCUMENTATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. THE TECHNICIAN NOTED IN THE EVALUATION NOTES THAT THE UNIT IS WORKING IN PARAMETERS AND THE SOFTWARE WAS UPDATED. 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. THE SERVICE TECHNICIAN ALSO NOTED DUST/DIRT AND TOBACCO CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729031 ↗MalfunctionMar 30, 2026Electrical /Electronic Property Problem
A BIPAP A30 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION; HOWEVER, VENTILATOR INOPERATIVE ERROR CODE INDICATING A FAILURE OF THE OUTLET PRESSURE SENSOR WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THERE WAS NO DOCUMENTATION OF ANY COMPONENT BEING REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728847 ↗MalfunctionMar 25, 2026Degraded
A BIPAP A30 DEVICE WAS RETURNED TO A 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. 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 BIPAP A30, THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. 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. THE SERVICE TECHNICIAN ALSO NOTED DIRT/DUST AND TOBACCO CONTAMINATION PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687034 ↗
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
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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