ResMed Stellar — Class I medical device recall Z-0915-2020
Completed recall by ResMed Ltd., reported 2020-02-12, distributed in CT, FL, GA, IL, MA, MT, PA, TN…. Combination of software and a component failure may cause audible alarms not to operate properly, the alarm bu
| Recall number | Z-0915-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | ResMed Ltd., Bella Vista, N/A, Australia |
| Recall initiated | 2019-12-12 |
| Classified | 2020-02-06 |
| Reported by FDA | 2020-02-12 |
| Distributed | CT, FL, GA, IL, MA, MT, PA, TN, VA |
| Quantity | 69 |
| Reason classes | software |
| Model numbers | 100, 150 |
Product
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0915-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.