www.fdanews.com/articles/143077-china-rsquo-s-department-of-health-issues-device-alert-for-cardiovascular-system
China’s Department of Health Issues Device Alert for Cardiovascular System
January 10, 2012
The Chinese Department of Health has issued a field safety notice for SynCardia Systems’ Companion 2 Driver system due to a connection failure that may cause the device to to alarm and lose power.