U.S. Food and Drug Administration02.20.20
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
Stellar non-invasive (air pushed through a mask or mouthpiece) and invasive (air pushed through a tube into the windpipe) ventilators are used to provide breathing support to adult and pediatric patients who are non-ventilator dependent and spontaneously breathing. These devices are used in hospitals, homes, or for mobile use with wheelchairs.
ResMed is recalling Stellar ventilators because the sound alarm may fail to work if:
The use of affected Stellar ventilators may cause serious adverse health consequences, including risk of serious injury or death. There has been one reported death.
Healthcare providers and facilities using Stellar 100 or 150 Ventilators and patients who receive breathing support using a Stellar 100 or 150 Ventilators may be affected.
On December 5, 2019, ResMed sent a Field Safety Notification to customers informing them of the affected models and provided the following instructions.
Do not use affected Stellar ventilators in patients that cannot have any breaks in breathing support or need a ventilator for life support. Perform a functional test that includes the use of alarms prior to each use. (See Stellar User Guide for more information):
Continue to follow all patient and device information in the Stellar User and Clinical Guides, with a focus on these sections:
Recalled Product
- Stellar Non-invasive and Invasive Ventilators
- Model Numbers: 100 and 150 with serial number range: 20160123307 to 22171057208
- Manufacturing Dates: April 2016 to June 2017
- Distribution Dates: April 2016 to November 2017
- Devices Recalled in the U.S.: 69
- Date Initiated by Firm: December 5, 2019
Stellar non-invasive (air pushed through a mask or mouthpiece) and invasive (air pushed through a tube into the windpipe) ventilators are used to provide breathing support to adult and pediatric patients who are non-ventilator dependent and spontaneously breathing. These devices are used in hospitals, homes, or for mobile use with wheelchairs.
ResMed is recalling Stellar ventilators because the sound alarm may fail to work if:
- the device has a failed electronic part,
- the device is stored without AC power connected for more than 36 hours letting the battery drain completely, or
- the device powers on automatically when connected to AC power without pressing the power switch.
The use of affected Stellar ventilators may cause serious adverse health consequences, including risk of serious injury or death. There has been one reported death.
Healthcare providers and facilities using Stellar 100 or 150 Ventilators and patients who receive breathing support using a Stellar 100 or 150 Ventilators may be affected.
On December 5, 2019, ResMed sent a Field Safety Notification to customers informing them of the affected models and provided the following instructions.
Do not use affected Stellar ventilators in patients that cannot have any breaks in breathing support or need a ventilator for life support. Perform a functional test that includes the use of alarms prior to each use. (See Stellar User Guide for more information):
- Press the power switch at the back of the device one time to turn on the device.
- Check that the alarm sounds a test beep.
- There will be a visual indicator (LEDs) for the alarm signal and the alarm mute button will flash.
Continue to follow all patient and device information in the Stellar User and Clinical Guides, with a focus on these sections:
- Functional test
- Working with alarms
- Internal battery
- Mobile use
