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www.fdanews.com/articles/142889-china-rsquo-s-department-of-health-issues-device-alert-for-monitoring-system

China’s Department of Health Issues Device Alert for Monitoring System

January 4, 2012
The Chinese Department of Health has issued a field safety notice for SynCardia Systems’ Freedom Driver system. The notice followed reports of a U.S. patient with intermittent low cardiac output alarms as a result of elevated systolic blood pressure readings.