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Recall Observatory FDA recall evidence

Device product

Astral 100 and Astral 150 ventilators

Z-0111-2024

September 13, 2023

Class I

Product summary

Firm
ResMed Ltd.
Event
Event 93122
Status
Ongoing
Classification
Class I
Quantity
55,279 (US 16,634; OUS 38,645)
Official record key
device-enforcement:Z-0111-2024

Official wording

Reason: 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

Code information: All devices manufactured between 2013 and 2019. Device label lists the serial number, which includes the year of manufacture. For example, if the serial number is 22151234567, the 3rd and 4th digit are 15, meaning the device was manufactured in 2015. Astral 100, UDI: 00619498003259 Astral 150, UDI: 00619498003266

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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