Recall Z-0002-2016— Biosense Webster, Inc.
Class II · Terminated
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2015-09-10, terminated 2016-05-13. It names one FDA 510(k) clearance: K133916. Product: 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: 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
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-10
- Terminated
- 2016-05-13
- Firm location
- Irwindale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.