Recall Z-0111-2024 ยท CBK Ventilator, Continuous, Facility Use
ResMed Ltd.
Astral 100 and Astral 150 ventilators
| Date | Oct 23, 2023 (initiated Sep 13, 2023) |
| Status | Open, Classified |
| 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 |
| 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 prima |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172875 | Astral 100/150 Resmed, Ltd., Apr 26, 2018 |