Recall Z-1230-2012 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster, Inc.
CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
| Date | Mar 20, 2012 (initiated Feb 9, 2012) |
| Status | Terminated |
| Reason | Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation. |
| Root cause | Nonconforming Material/Component |
| Action | Three Urgent Customer Notification recall communications were initiated 2/9/12 with Biosense forwarding the notification to customers with affected backplane cards (electrophysiology lab managers, a notification for customers with affected back plane cards (risk managers), and a notification for customers with affected backplane cards and smarttouch module along with customer acknowledgement forms. The letters provides the customers with an explanation of the problem identified and steps to take in the event that the issue is observed. If the steps provided do not resolve the issue, customer |
| Quantity | 134 units total (32 units in US) |
| Distribution | Worldwide Distribution -- US, Japan, China, Ireland, Germany, Italy, Slovenia, Indonesia, Poland, Spain, United Kingdom, Switzerland, Belgium, and Canada. |
| 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 |
| K093455 | CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES Biosense Webster, Inc., Dec 4, 2009 |
| K103746 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) Biosense Webster, Inc., Jan 21, 2011 |
| K112007 | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 Biosense Webster, Inc., Oct 5, 2011 |