Biosense Webster
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Biosense Webster and translate it into plain English — free weekly digest, optional same-day alerts.
- 2015-10-07FDA-DeviceClass IIContact your cardiologist about SOUNDSTAR eco catheters
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.
- 2015-10-07FDA-DeviceClass IIContact Biosense Webster about CARTO 3 system
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.
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