FDA Medical Device Recalls (openFDA)
ResMed Ltd.: ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
- Recall number
- Z-0915-2020
- Recalling firm
- ResMed Ltd.
- Product
- ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
- Status
- Completed
- Initiated
- 2019-12-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 69
- Distribution
- U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
- Lot, serial or model codes
- Serial Number Range: 20160123307 to 22171057208
- 510(k) numbers
- ["K122715"]
- PMA numbers
- not on file
- Product code
- MNT
- Firm FEI
- 3004604967
- Firm city
- Bella Vista
- Firm state
- not on file
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28