FDA-Device2015-10-07Class IIPROCESSING DEFECT

Biosense Webster CARTO 3 EP Navigation System cardiac ultrasound image loss during restart

OTHERNationwide distribution

Contact Biosense Webster about CARTO 3 system

The CARTOSOUND module of the CARTO 3 EP Navigation System can lose ultrasound images when the system restarts during certain cardiac procedures. This affects the system when used with SOUNDSTAR eco catheters. No injuries have been reported.

If you operate this system, contact Biosense Webster for updated precautions and guidance
Review the new precautions provided by the manufacturer before your next procedure

Hazard

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.

Sold states

Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.

Affected count

1035 (U.S.)

Manufactured in

15715 Arrow Hwy, N/A, Irwindale, CA, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2016

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