REMstar System One 60 Series REMstar Auto, INTLRecalls & reported problems

Respironics, Inc. · REMstar Auto, International · 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 breathing device has 349 adverse event reports on file, including 1 death and 11 injuries. Most reports describe the sound-reducing foam breaking down, and some mention headaches, coughing and shortness of breath. No recalls name this device. Reports from the last 12 months rose to 155 from 3 in the prior 12 months.

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: 349
Deaths reported: 1
Injuries reported: 11
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 349 adverse event reports that list this exact device (DI 00606959030572), received between May 25, 2021 and Mar 12, 2026 — classified as 1 death, 11 injuries, 337 malfunctions.

The most frequently reported specific device problem is “Degraded” (347 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, 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Degraded347
Adverse Event Without Identified Device or Use Problem1
Contamination1
Material Integrity Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions293
Headache24
Cough10
Unspecified Respiratory Problem10
Dyspnea8
Nausea8
Fatigue6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5

Recent adverse event reports

The 25 most recent of 349 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 12, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580947 ↗
MalfunctionMar 2, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481320 ↗
MalfunctionFeb 27, 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 THEY CONFIRM THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468265 ↗
MalfunctionFeb 27, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468259 ↗
MalfunctionFeb 26, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24452084 ↗
MalfunctionFeb 25, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440547 ↗
MalfunctionFeb 25, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440462 ↗
MalfunctionFeb 25, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440060 ↗
MalfunctionFeb 25, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438847 ↗
MalfunctionFeb 25, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438843 ↗
MalfunctionFeb 25, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438830 ↗
MalfunctionFeb 25, 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 THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438829 ↗
MalfunctionFeb 25, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438761 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438622 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438619 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438614 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438567 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437665 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437661 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437659 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437226 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437222 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437214 ↗
MalfunctionFeb 24, 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. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437211 ↗
MalfunctionFeb 24, 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 WAS NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428194 ↗

Device details

UDI-DI	`00606959030572`
Brand	REMstar System One 60 Series
Model	REMstar Auto, INTL
Catalog no.	561P
Company	Respironics, Inc.
Product code	BZD · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 24, 2021

Device type (GMDN): Home CPAP unit

A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

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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.

How reports and recalls are matched · Editorial policy · Report an error on this page