REMstar System One 60 Series REMstar Auto A-Flex, System One 60 Series, GermanyRecalls & reported problems
Respironics, Inc. · REMstar Auto A-Flex, System One 60 Series, Germany · Class 2
All models of REMstar System One 60 Series (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Respironics REMstar Auto A-Flex ventilator has 79 adverse event reports, including 1 death and 11 injuries, mostly describing foam breaking down inside the device, foam particles, overheating, and burnt parts. Most reports mention no clinical symptoms, though some mention cough, headache, or respiratory problems. No recalls name this device. Reports rose sharply in the last 12 months compared with the previous 12 months (25 vs 3).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00606959030503), received between Jul 21, 2021 and Jun 22, 2026 — classified as 1 death, 11 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Degraded” (71 reports).
2 other recalls cover devices cleared under the same FDA submission (K113068); 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.
Reports received per month
Most reported problems
Device problems
- Degraded71
- Contamination8
- Overheating of Device6
- Thermal Decomposition of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Cough7
- Headache5
- Cancer4
- Unspecified Respiratory Problem4
- Insufficient Information3
- Dizziness2
- Dyspnea2
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST/DIRT CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586479 ↗MalfunctionApr 14, 2026Degraded
A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE SOUND ABATEMENT RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WAS FOUND INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION, AND 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 DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877343 ↗MalfunctionMar 9, 2026Overheating of Device
A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552594 ↗MalfunctionMar 9, 2026Overheating of Device
A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551791 ↗MalfunctionMar 7, 2026Overheating of Device
A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540714 ↗MalfunctionMar 6, 2026Overheating of Device
A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539605 ↗MalfunctionFeb 25, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441585 ↗MalfunctionFeb 25, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441498 ↗MalfunctionFeb 25, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441491 ↗MalfunctionFeb 25, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441358 ↗MalfunctionFeb 24, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431814 ↗MalfunctionFeb 24, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DETERIORATED FOAM. ADDITIONALLY, DUST/DIRT WAS FOUND INSIDE THE DEVICE, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426953 ↗MalfunctionFeb 24, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. IN ADDITION, DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426951 ↗MalfunctionFeb 24, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. IN ADDITION, FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426748 ↗MalfunctionFeb 24, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. IN ADDITION, FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426746 ↗MalfunctionFeb 23, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. IN ADDITION, DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411260 ↗MalfunctionFeb 23, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY. IN ADDITION, TOBACCO CONTAMINATION AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411258 ↗MalfunctionFeb 18, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. IN ADDITION, TOBACCO CONTAMINATION AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24374888 ↗MalfunctionFeb 17, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363022 ↗MalfunctionFeb 17, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362939 ↗MalfunctionFeb 17, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362561 ↗MalfunctionFeb 17, 2026Degraded
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. A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362413 ↗MalfunctionFeb 16, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343395 ↗MalfunctionFeb 16, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DAMAGED FOAM THAT CANNOT BE DISASSEMBLED FROM THE CHASSIS. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341842 ↗MalfunctionFeb 16, 2026Degraded
A REMSTAR AUTO A-FLEX 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 THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341798 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K113068. One submission often covers many models, so check the product and lot details in each record.
- Z-1817-2024 · Apr 1, 2024 · Open, ClassifiedOmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
- Z-1974-2021 · Jun 14, 2021 · Open, ClassifiedSystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
- REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)117 deaths10,075 reports
- DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)106 deaths5,937 reports
- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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