Astral 100 and Astral 150 ventilators
Reported: November 1, 2023 Initiated: September 13, 2023 #Z-0111-2024
Product Description
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
Details
- Recalling Firm
- ResMed Ltd.
- Units Affected
- 55,279 (US 16,634; OUS 38,645)
- 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, Maldives, Denmark, Poland.
- Location
- Bella Vista, N/A
Frequently Asked Questions
What product was recalled? ▼
Astral 100 and Astral 150 ventilators. Recalled by ResMed Ltd.. Units affected: 55,279 (US 16,634; OUS 38,645).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2023. Severity: Critical. Recall number: Z-0111-2024.
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