Recall Z-1966-2023 ยท CBK Ventilator, Continuous, Facility Use
Vyaire Medical
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
| Date | Jun 15, 2023 (initiated May 5, 2023) |
| Status | Completed |
| Reason | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified its consignees by email on 04/27/2023. The notice explained the issue, the risk to health and requested the following: ACTIONS TO BE TAKEN BY CONSUMERS/END USERS 1. Confirm receipt and thoroughly review the contents of the Customer Notification package. 2. If affected devices are transferred to another location or organization, forward the complete Customer Notification package to the respective users. 3. To reduce the change that the AppHang error will occur, Vyaire recommends that when the )2 suction maneuver is active, the end user should not attempt to activate any c |
| Quantity | 910 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183364 | Bellavista Imtmedical AG, Sep 13, 2019 |