Recall Z-0002-2016 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster, Inc.
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.
| Date | Oct 1, 2015 (initiated Sep 10, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site. The firm's notification letter stated that they want to emphasize the following statement "The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ul |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133916 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 Biosense Webster, Inc., Jul 1, 2014 |