# FDA recall Z-0915-2020

> **ResMed Ltd.** · Class I · device recall initiated 2019-12-12.

## 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.

## Distribution

U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT

## Key facts

- **Recall number:** Z-0915-2020
- **Recalling firm:** ResMed Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-12-12
- **Report date:** 2020-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bella Vista, N/A, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0915-2020

## Citation

> AI Analytics. FDA recall Z-0915-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0915-2020. Source: US FDA. Licensed CC0.

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