Z-0111-2024Class I

Astral 100 and Astral 150 ventilators

Name: Z-0111-2024 Astral 100 and Astral 150 ventilators
Creator: ResMed Ltd.
Published: 2023-09-13
License: https://open.fda.gov/license/

ResMed Corp / initiated 2023-09-13 / Open, Classified / root cause: design

FDA source

ResMed Ltd. began a recall of Astral 100 and Astral 150 ventilators on 2023-09-13. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0111-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-13
Posted: 2023-10-23
Recalling firm: ResMed Corp
Product: Astral 100 and Astral 150 ventilators
Product code: CBK Ventilator, Continuous, Facility Use
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
Root cause tag: design
FDA root cause: Device Design
Action: On 9/13/23 Field Safety Notices were emailed to distributors, institutions, medical facilities. The notices states to immediately provide a copy of the notice and the patient/carer letter to all patients, carers, and relevant healthcare professionals. The notices states: Continue using your Astral ventilator, provided you continue to follow the instructions detailed in the Astral User Guide. -Connect the ventilator to mains power whenever possible. In the event of battery failure, connect to mains power immediately to resume ventilation. - Internal battery is not intended to serve as a primary power source. It should only be used when other sources are not available or briefly when necessary. -External power source should always be available for ventilator-dependent patients. -External power source should be in use in mobile situations, including when mains power is unavailable or disrupted. Do not rely solely on the internal battery for mobile use. - Ensure the external battery is sufficiently charged before using in mobile situations. - For ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device. - Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers. Consistently follow the 2-year ventilator preventative maintenance schedule to help detect and replace circuit boards with degraded supercapacitors. A second phase will be communicated to customers. Follow the updated service process detailed in Tech Note 1063673; not sent to patients/carers. Complete/return the acknowledgment form: [email protected]. Questions - contact your local ResMed contact. On 3/18/24, a second Field Safety Notice was sent requesting that devices be returned to a Service Center as soon as possible, but no later than the end of March 2025 to receive software update R6.2 (SX544-0603).
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0111-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23

Product code CBK

K172875Class IIAstral 100/150Resmed, Ltd. / cleared 2018-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)