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 CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA on 9/10/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1035 (U.S.)
DISTRIBUTION
Nationwide and Internationally
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