www.fdanews.com/articles/142951-china-rsquo-s-department-of-health-issues-device-alert-for-heart-system
China’s Department of Health Issues Device Alert for Heart System
January 5, 2012
The Chinese Department of Health has issued a field safety notice for HeartWare’s HeartWare Controller. The notice followed reports of alarm limits being exceeded without an audible notification or visible alarm message.