Company: Biosense Webster, Inc.Date of Enforcement Report 10/7/2015 Class lI: PRODUCT SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. Recall Number Z-0003-2016 REASON Image disappeared from the cardiac ultrasound system when the...Read More

Company: Biosense Webster, Inc.Date of Enforcement Report 10/7/2015 Class lI: PRODUCT Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. Recall Number Z-0002-2016 REASON Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed...Read More