REMstar System One 60 SeriesRecalls & reported problems across all models

Respironics, Inc. · 92 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 37,934
Deaths reported: 441
Injuries reported: 6,058
Recalls: 0

We found 92 models of REMstar System One 60 Series by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 37,934 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2016 and Sep 30, 2026 — classified as 441 deaths, 6,058 injuries, 31,435 malfunctions.

The most frequently reported specific device problem is “Degraded” (37,639 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. 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

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

Most reported REMstar System One 60 Series problems

Device problems

Degraded37,639
Contamination4,945
Overheating of Device995
Adverse Event Without Identified Device or Use Problem153
Material Integrity Problem56
Contamination /Decontamination Problem42
Device Contamination with Chemical or Other Material35
Thermal Decomposition of Device27

Patient problems

No Clinical Signs, Symptoms or Conditions27,866
Unspecified Respiratory Problem3,893
Headache2,740
Cancer2,592
Dizziness2,118
Asthma1,707
Unspecified Kidney or Urinary Problem1,415
Dyspnea1,177

REMstar System One 60 Series models

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

REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
117 deaths10,075 reports
REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
64 deaths5,138 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
65 deaths4,520 reports
REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
43 deaths4,149 reports
REMstar System One 60 Series REMstar Pro C-Flex+ System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
36 deaths2,206 reports
REMstar System One 60 Series REMstar Plus, w/Humid System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
24 deaths1,478 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/HT Humid System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
12 deaths1,324 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series LA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1,161 reports
REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series FR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1,115 reports
REMstar System One 60 Series REMstar Auto, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
22 deaths699 reports
REMstar System One 60 Series REMstar Auto A-Flex, w/H Tube Humid, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
3 deaths629 reports
REMstar System One 60 Series REMstar Plus System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
4 deaths616 reports
REMstar System One 60 Series REMstar Auto A-Flex, with Humidifier, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
9 deaths585 reports
REMstar System One 60 Series REMstar Auto, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death349 reports
REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 deaths347 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death311 reports
REMstar System One 60 Series REMstar Pro, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
16 deaths306 reports
REMstar System One 60 Series REMstar Pro, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
275 reports
REMstar System One 60 Series REMstar Auto P-Flex, System One 60 Series, France
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death209 reports
REMstar System One 60 Series REMstar Plus, w/HT Humid System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 deaths182 reports
REMstar System One 60 Series REMstar Auto A-Flex, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death180 reports
REMstar System One 60 Series REMstar Auto, BR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
157 reports
REMstar System One 60 Series REMstar Auto A-Flex w/ Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 deaths149 reports
REMstar System One 60 Series REMstar Auto A-Flex with Humidifier, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
141 reports
REMstar System One 60 Series REMstar Pro C-Flex+, with Humidifier, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death127 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H Tube Humid, w/St Tube, 60 Srs, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death124 reports
REMstar System One 60 Series REMstar Pro C-Flex, System One 60 Series, France
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
97 reports
REMstar System One 60 Series REMstar Pro C-Flex+ w/ Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death92 reports
REMstar System One 60 Series REMstar Pro C-Flex+ w/HT Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
91 reports
REMstar System One 60 Series REMstar Pro C-Flex+, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
86 reports
REMstar System One 60 Series REMstar Auto A-Flex, System One 60 Series, Germany
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death79 reports
REMstar System One 60 Series REMstarAuto A-Flex w/Humid, w/Bluetooth,60 Srs, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death70 reports
REMstar System One 60 Series REMstar Auto A-Flex, BTOOTH System One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death55 reports
REMstar System One 60 Series REMstar Plus C-Flex, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
51 reports
REMstar System One 60 Series REMstar Pro C-Flex+, 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
43 reports
REMstar System One 60 Series REMstar Pro C-Flex+, with Humidifier, 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
41 reports
REMstar System One 60 Series REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
40 reports
REMstar System One 60 Series REMstar Plus, with Humidifier, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
40 reports
REMstar System One 60 Series REMstar Auto A-Flex, w/H Tube Humid, St Tube, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
40 reports
REMstar System One 60 Series REMstar Auto A-Flex, w/H Tube Humid, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
40 reports
REMstar System One 60 Series REMstar Pro C-Flex+, System One 60 Series, Germany
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death37 reports
REMstar System One 60 Series REMstar Auto A-Flex, System One 60 Series, GB
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 deaths37 reports
REMstar System One 60 Series REMstar Auto A-Flex, 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
35 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death33 reports
REMstar System One 60 Series REMstar Auto w/HTD Humid, BlueTooth, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death32 reports
REMstar System One 60 Series REMstar Pro C-Flex+, BR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
24 reports
REMstar System One 60 Series REMstar Plus, w/H Tube Humid, Standard Tube, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
22 reports
REMstar System One 60 Series REMstar Pro, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
22 reports
REMstar System One 60 Series REMstar Auto, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death20 reports
REMstar System One 60 Series REMStar Auto w/BlueTooth, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
20 reports
REMstar System One 60 Series REMstar Auto A-Flex, with Humidifier, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
18 reports
REMstar System One 60 Series REMstar Pro C-Flex+, System One 60 Series, GB
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
17 reports
REMstar System One 60 Series REMstar Plus, w/H Tube Humid, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
16 reports
REMstar System One 60 Series REMstar Pro C-Flex+, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
16 reports
REMstar System One 60 Series REMstar Plus C-Flex, w/H Tube Humid, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
13 reports
REMstar System One 60 Series REMstar Auto, CN
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
13 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H Tube Humid, w/Btooth, 60 Srs, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
12 reports
REMstar System One 60 Series System One Heated Humidifier US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
10 reports
REMstar System One 60 Series REMstar Auto A-Flex W/SD Card JP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
10 reports
REMstar System One 60 Series REMstar Auto A-Flex, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
9 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
9 reports
REMstar System One 60 Series REMstar Auto A-Flex, with Humidifier, 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
8 reports
REMstar System One 60 Series REMstar Pro C-Flex+, BlueTooth Sys One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
8 reports
REMstar System One 60 Series REMstar Pro C-Flex+, with Humidifier, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
8 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 reports
REMstar System One 60 Series REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 reports
REMStar System One 60 Series REMStar Pro, w/BlueTooth, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 reports
REMstar System One, 60 Series REMstar Auto A-Flex, System One 60 Series, FR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 reports
REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series LA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
5 reports
REMstar System One 60 Series REMstar Auto A-Flex, System One, 60 Series, DE
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
5 reports
REMstar System One 60 Series REMstar Auto A-Flex, BR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
4 reports
REMstar System One 60 Series REMstar Auto JP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
4 reports
REMstar System One 60 Series REMstar Auto A-Flex, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
3 reports
REMstar System One 60 Series REMstar Plus, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid, with BTooth, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/H T Hum, St Tube, BTooth, 60 Srs, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
REMStar System One 60 Series REMStar Auto, with BlueTooth, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
REMstar System One 60 Series REMstar Plus, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Pro C-Flex+, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Auto A-Flex, w/HT Humid System One 60 Srs CN
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Auto A-Flex, with Bluetooth, 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Plus C-Flex, with Humidifier, 60 Series, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Plus C-Flex, System One 60 Series, Latin America
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Plus, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Pro C-Flex+, with BlueTooth, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid, System One 60 Srs,GB
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Auto C-Flex+ w/Humid, BlueTooth, 60 Srs, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Auto A-Flex, w/Humid, System One 60 Srs, GB
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Auto P-Flex, FR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Auto w/Htd Humid, St Tube, w/Btooth, 60 Srs, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Pro C-Flex+, System One 60 Series, DE
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
REMstar System One 60 Series REMstar Plus C Flex, System One 60 Series, Italy
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report

Recent REMstar System One 60 Series adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955082 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954741 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954668 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954665 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954664 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953071 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951906 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950683 ↗
MalfunctionSep 30, 2026Degraded
A REMstar Pro C-Flex+ device was returned to a third-party service center with no initial alleged complaint. There was no report of serious or permanent harm or injury, and there was no report of medical intervention.During the evaluation of the device, the service technician observed visible foam particles. Additionally, unrelated to the reportable malfunction, the technician observed dust contamination, and 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 the error codes caused or contributed to 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 50945743 ↗
MalfunctionSep 30, 2026Degraded
A REMstar Auto device was returned to a third-party service center for service as part of the sound abatement foam recall process. During the evaluation of the device, the service technician observed visible foam particles. During the evaluation, there was dust contamination found in the device. The device was scrapped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941778 ↗
MalfunctionSep 29, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938277 ↗
MalfunctionSep 29, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938276 ↗
MalfunctionSep 29, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937742 ↗
MalfunctionSep 29, 2026Degraded
A REMstar Pro C-Flex+ device was returned to a third-party service center for service as part of the sound abatement foam recall process. During the evaluation of the device, the service technician observed visible foam particles. During the evaluation, there was dust contamination found in the device. The device was scrapped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936745 ↗
MalfunctionSep 29, 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 an unspecified fluid 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 50935331 ↗

Other Respironics, Inc. products

All Respironics, Inc. devices →

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.

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