Recall Z-0746-2016 ยท CBK Ventilator, Continuous, Facility Use
Resmed Corporation
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the
| Date | Feb 3, 2016 (initiated Jan 13, 2016) |
| Status | Terminated |
| Reason | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. |
| Root cause | Software design |
| Action | ResMed sent an Urgent Safety Alert dated January 13, 2016, to all affected customers. The Alert identified the product, the problem, and the action to be taken by the customer. The notification letter provided the following instructions to distributors Field devices can be upgraded using ResMed Service Software or at an authorized ResMed Service Center. Contact Astral Support for further details. The SR2 software update will be available free of charge and should be implemented for all devices within the two-year service cycle or before at the customers preference. To acknowledge recei |
| Quantity | 14,736 |
| Distribution | Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133868 | ASTRAL VENTILATOR Resmed, Ltd., Jun 4, 2014 |