bellavista 1000 and 1000e Series Ventilators Recalled Due to Software Configurations

Serious adverse events may result from the use of these devices. This is as a Class I recall, the most serious type of recall.

If your email program has trouble displaying this email, view as a webpage. Vyaire Medical Recalls Bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations Vyaire Medical is recalling the bellavista 1000 and 1000e Series Ventilators after reports of ventilators failing to ventilate and generating a technical failure alarm, with specific software versions and configure combinations. If this occurs, it may cause serious adverse events. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? If you have questions about this recall, contact Vyaire Medical at 833-327-3284 between 5 a.m. and 5 p.m. PST, Monday through Friday, or email GMB-AMS-FSCAresponsecentre@vyaire.com.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA