Recall Z-2369-2012 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster, Inc.
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acq
| Date | Sep 12, 2012 (initiated Nov 17, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System. |
| Root cause | Labeling mix-ups |
| Action | Biosense Webster sent an " URGENT FIELD SAFETY NOTICE" dated November 20, 2009 to all affected customers who purchased the Carto 3 Electrophysiology Mapping System. The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to continue use of the CARTO 3 System and that it was safe and no further action is needed. Customers with questions about the notice were instructed to contact Biosense Webster representatives. On January 12, 2010 another letter was sent from Biosense to all their customers recommending to avoid any connection of |
| Quantity | 71 units total (30 units in US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES Biosense Webster, Inc., Oct 13, 2009 |