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U.S. Department of Health and Human Services

Class 2 Device Recall CARTO 3 Systems

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  Class 2 Device Recall CARTO 3 Systems see related information
Date Initiated by Firm February 09, 2012
Date Posted March 20, 2012
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-1230-2012
Recall Event ID 61197
510(K)Number K090017  K093455  K103746  K112007  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product CARTO 3 Systems, Product Code M-4800-01

The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
Code Information Catalog # FG-5400-00  Serial numbers: 11996, 11998, 11999, 12002, 12026, 12031, 12040, 12046, 12047, 12051, 12052, 12057, 12061, 12062, 12063, 12065, 12066, 12067, 12069, 12070, 12075, 12077, 12078, 12086, 12087, 12088, 12089, 12094, 12096, 12098, 12099, and 12111.
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Mina Ghajar
909-839-8874
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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, customers are to contact their Biosense Webster representative. A Biosense Webster representative will contact customers to schedule an appointment for the replacement of the Backplane card. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. If customers have questions, they can contact their BWI representative.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = BIOSENSE WEBSTER, INC.
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