Recall Z-0915-2020 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
ResMed Ltd.
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
| Date | Dec 12, 2019 |
| Status | Completed |
| Reason | Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch. |
| Root cause | Device Design |
| Action | On 12/12/19, Urgent Field Safety Notifications were emailed to customers reinforcing user instructions. Use should be consistent with indications for use. Perform a functional test including alarms as described in the "Starting therapy" section in the User guide prior to each use. Press the power switch at the back of the device once to turn on the device. Check that the alarm sounds a test beep and the LEDs (visual indicator) for the alarm signal and the Alarm mute button flash. The firm is developing a device correction to address this issue. When this is available the firm will contact aff |
| Quantity | 69 |
| Distribution | U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122715 | STELLAR 150 Resmed Germany, Inc., Jun 17, 2013 |