# FDA recall Z-0111-2024

> **ResMed Ltd.** · Class I · device recall initiated 2023-09-13.

## Product

Astral 100 and Astral 150 ventilators

## Reason for recall

If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all

## Distribution

Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO, TX, AL, LA, MD, OR, AZ, MN, WA, PA, SC, MA, ID, GA, SD, TN, NH, OH, MS, CT, IA, KY, UT, NE, MO, NV, AR, WY, RI, KS, VT, ME, OK, PR, MO, DC and the countries of Taiwan, Israel, Spain, Slovenia, Belgium, Italy, Australia, Guatemala, Argentina, Uruguay, Chile, France, Martinique, Germany, French Polynesia, Korea, Egypt, Colombia, United Kingdom, Jersey, Ecuador, Reunion, Greece, Brazil, Cyprus, Saudi Arabia, Czech Republic, Thailand, New Caledonia, Mauritius, Canada, Vietnam, Indonesia, Pakistan, Japan, Guadeloupe, South Africa, Iran, Hungary, Tunisia, Nepal, Iceland, New Zealand, Austria, Portugal, Malaysia, Norway, Netherlands, Sweden, Lebanon, Finland, Singapore, United Arab Emirates, Peru, Oman, Philippines, Bahrain, French Guiana, Mexico, Sri Lanka, India, Kuwait, Bangladesh, Kenya, Myanmar, Turkey, Bulgaria, Croatia, Hong Kong, Saint Martin, Qatar, Jordan, Romania, M

## Key facts

- **Recall number:** Z-0111-2024
- **Recalling firm:** ResMed Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-13
- **Report date:** 2023-11-01

- **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-0111-2024

## Citation

> AI Analytics. FDA recall Z-0111-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0111-2024. Source: US FDA. Licensed CC0.

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