Z-0915-2020Class I

ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

Name: Z-0915-2020 ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Creator: ResMed Ltd.
Published: 2019-12-12
License: https://open.fda.gov/license/

ResMed Corp / initiated 2019-12-12 / Completed / root cause: design

FDA source

ResMed Ltd. began a recall of ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 on 2019-12-12. FDA classified it as Class I and gives the reason as "Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0915-2020
Classification: Class I
Status: Completed
Initiated: 2019-12-12
Posted: 2020-02-07
Recalling firm: ResMed Corp
Product: ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
Root cause tag: design
FDA root cause: Device Design
Action: On 12/12/19, Urgent Field Safety Notifications were emailed to customers reinforcing user instructions. Use should be consistent with indications for use. Perform a functional test including alarms as described in the "Starting therapy" section in the User guide prior to each use. Press the power switch at the back of the device once to turn on the device. Check that the alarm sounds a test beep and the LEDs (visual indicator) for the alarm signal and the Alarm mute button flash. The firm is developing a device correction to address this issue. When this is available the firm will contact affected customers with specific actions at that time. Actions to be taken by healthcare professionals and users: The device is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. It is important to assess changes in a patient's dependence on mechanical ventilation, particularly if their condition is progressive. If a patient is ventilator dependent, consider consulting their physician to discuss changing the patient to an appropriate device such as a life support device. Please continue to follow all patient and device information in the User and Clinical Guides, in particular, the following sections: Performing a functional test, Working with alarms, Internal battery, and Mobile use. As always, if there are any concerns regarding device behavior and operation, please contact your local customer service contact to organize a service. Actions to be taken by distributors and healthcare providers: Please forward this notice to your affected customers and physicians. For any questions, please call (855) 245-4640.
Quantity in commerce: 69
Distribution: U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Product codes and lots: Serial Number Range: 20160123307 to 22171057208

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0915-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0915-2020	Class I	Completed	Voluntary: Firm initiated	2020-02-12	2020-02-06

Product code MNT

K122715Class IIStellar 150Resmed Germany, Inc. / cleared 2013-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)