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.
Reported: October 7, 2015 Initiated: September 10, 2015 #Z-0002-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- 1035 (U.S.)
- Distribution
- 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.
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biosense Webster, Inc.. Units affected: 1035 (U.S.).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2015. Severity: Moderate. Recall number: Z-0002-2016.
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