Recall Z-2776-2016 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster, Inc.
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
| Date | Sep 9, 2016 (initiated Aug 15, 2016) |
| Status | Terminated |
| Reason | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU). |
| Root cause | Under Investigation by firm |
| Action | Biosense Webster sent a Customer Notification letter dated August 23, 2016, to all affected customers to inform them that Biosense Webster, Inc. recently became aware that some systems were improperly transported and installed at hospitals in China by Biosense Webster, Inc. Clinical Specialists. The letter informs the customers that according to the CARTO 3 System Instructions for Use (IFU), only the Biosense Webster, Inc. Technical Services team members are authorized to properly install the systems. Customers are informed that each impacted CARTO 3 System must be fully tested and approved b |
| Quantity | 338 units |
| Distribution | International Distribution to China, Hong Kong and Brazil. |
| FDA record | Open on fda.gov |