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U.S. Department of Health and Human Services

Class 1 Device Recall Astral 100 and Astral 150 ventilators

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  Class 1 Device Recall Astral 100 and Astral 150 ventilators see related information
Date Initiated by Firm September 13, 2023
Date Posted October 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-0111-2024
Recall Event ID 93122
510(K)Number K172875  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Astral 100 and Astral 150 ventilators
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
Recalling Firm/
Manufacturer		 ResMed Ltd.
1 Elizabeth Macarthur Dr
Bella Vista Australia
For Additional Information Contact Dawn Haake
619-207-7142
Manufacturer 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
FDA Determined
Cause 2		 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: astral-postmarket@resmed.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = ResMed Ltd
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