REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid, System One 60 Srs,GBRecalls & reported problems

Respironics, Inc. · REMstar Pro C-Flex+, with Humidifier, System One 60 Series,GB · Class 2

All models of REMstar System One 60 Series (92)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959030312), received between Mar 23, 2026 and Mar 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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

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

Most reported problems

Device problems

Degraded1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 23, 2026Degraded
A REMSTAR PRO C-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, DUST/DIRT WAS FOUND INSIDE THE DEVICE, AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659513 ↗

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

Device details

UDI-DI	`00606959030312`
Brand	REMstar System One 60 Series
Model	REMstar Pro C-Flex+, w/Humid, System One 60 Srs,GB
Catalog no.	GB461HS
Company	Respironics, Inc.
Product code	BZD · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Class	Class 2
FDA submission	K113068
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 23, 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.

Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices

REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
117 deaths10,075 reports
DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
106 deaths5,937 reports
DreamStation DreamStation Auto CPAP with Humidifier, US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
44 deaths5,793 reports
REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
64 deaths5,138 reports
REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series US
Respironics, 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, US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
43 deaths4,149 reports
DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
30 deaths3,981 reports
DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, US
Respironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
86 deaths3,516 reports

All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices →

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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