REMstar System One 60 Series REMstar Auto A-Flex, System One, 60 Series, DERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959037892), received between Aug 4, 2022 and Apr 24, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 24, 2026Degraded

  A 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. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION AND DUST CONTAMINATION. 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 DEVICE HAS BEEN SCRAPPED. 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 24989546 ↗
• MalfunctionApr 24, 2026Degraded

  A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983229 ↗
• MalfunctionApr 23, 2026Degraded

  A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO THE 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 INITIAL ALLEGED COMPLAINT FOUND. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN FOUND 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 AS PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965908 ↗
• InjuryAug 22, 2024Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED ABOUT A VOLUNTARY FIELD SAFETY NOTICE/RECALL RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED REPORTS ALLEGING THAT THE PATIENT EXPERIENCED DAMAGE TO THE LUNG TISSUE, SHORTNESS O BREATH AND FEAR OF SERIOUS INJURY. NO SPECIFIC MEDICAL INTERVENTION WAS MENTIONED. THE MANUFACTURER WAS MADE AWARE OF THIS INFORMATION THROUGH THE CUSTOMER¿S LEGAL REPRESENTATIVE. DUE TO POTENTIAL LEGAL ISSUES SURROUNDING THIS CASE, NO FURTHER INVESTIGATION OR FOLLOW-UP CAN BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 20040284 ↗
• InjuryAug 4, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED PROBLEMS WITH CIRCULATION AND EXHAUSTION, HIGH BLOOD PRESSURE AND PALPITATIONS. THE PATIENT DID REPORT TO RECEIVE MEDICAL INTERVENTION AND HAVE SEEN A PULMONOLOGIST AND RECEIVING MEDICAL TREATMENT TWICE A YEAR WITH NO FURTHER DIAGNOSIS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Arrhythmia; Fatigue; High Blood Pressure/ Hypertension

  MAUDE report 15166254 ↗

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, Classified
  OmniLab 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, Classified
  SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide