FDA Device recall Z-0915-2020
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
- FDA Device
- Class I
- completed
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class I recall of ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 by Resmed, citing 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 componen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0915-2020 |
| Classification | Class I |
| Status | completed |
| Initiated | 2019-12-12 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Resmed |
| Distribution | CT, FL, GA, IL, MA, MT, PA, TN, VA |
Product
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
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.
Identifiers
| code_info | Serial Number Range: 20160123307 to 22171057208 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0915-2020%22
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