{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221232", "product_res_number": "Z-2735-2026", "event_date_initiated": "2026-06-25", "event_date_posted": "2026-07-28", "recall_status": "Open, Classified", "res_event_number": "99304", "product_code": "CBK", "k_numbers": [ "K152068", "K172875" ], "product_description": "Resmed Astral 100/150\n\nResmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.", "code_info": "Catalog Number: Astral 100\nUDI-DI code: 00619498003259\nSerial Numbers:\nAstral Ventilators-Serial number < 22241890149\nPCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658\nPCBA Spare Parts in Box - Box serial number < 22241978070\n\nCatalog Number: Astral 150\nUDI-DI code: 00619498270033\nSerial Numbers:\nAstral Ventilator-Serial numbers < 22241440282\nPCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658\nPCBA Spare Parts in Box - Box serial number < 22241978070", "firm_fei_number": "3004604967", "recalling_firm": "ResMed Ltd.", "address_1": "1 Elizabeth Macarthur Dr", "city": "Bella Vista", "country": "Australia", "reason_for_recall": "Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.", "root_cause_description": "Component design/selection", "action": "ResMed Urgent Medical Device Correction Astral 100/150 Ventilators\nIssue Identified: On June 25, 2026, ResMed notified customers via Salesforce of an urgent medical device correction involving a subset of Astral 100 and Astral 150 ventilators. An internal supercapacitor may leak electrolyte over time, potentially damaging the printed circuit board assembly (PCBA) and causing the ventilator to enter a fail-safe state.\n\nInterim Guidance: Due to limited PCBA replacement availability, immediate correction of all affected units is not feasible. Physicians and patients are advised to follow Astral 100/150 User and Clinical Guides, including recommendations on monitoring, emergency preparedness, caregiver training, and backup ventilation.\n\nRequired Actions for Healthcare Providers and Distributors:\n\nAcknowledge: Complete and return the acknowledgment form by July 31, 2026.\nNotify: Distribute the correction notice and accompanying letters to all relevant healthcare professionals, patients, and caregivers immediately.\nReinforce Safety Measures: Ensure ventilator-dependent patients are monitored, caregivers are trained in alarm response and emergency procedures, and backup ventilation equipment is functional and readily available.\nDevice Management: Do not remove an affected ventilator from use unless an alternative is immediately available. Replace inoperable units promptly; patients should continue therapy unless directed otherwise by their clinician.\nRisk Assessment: Evaluate affected patients by clinical risk category (Tier 1, 2, or 3) per Appendix A.\nArrange Inspection: Schedule ventilator inspections per the Phase 1 Inspection and Correction Strategy in Appendix A, returning units to an authorized service center as needed.\nContact: Reach your local ResMed representative or visit www.resmed.com/contact for questions.", "product_quantity": "168,069 devices globally", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Martin (French part), Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Viet Nam.", "openfda": { "k_number": [ "K173060", "K896736", "K802168", "K822040", "K232365", "K040790", "K061094", 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Continuous, Facility Use", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ] }