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U.S. Department of Health and Human Services

Class 2 Device Recall CARTO 3 System

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 Class 2 Device Recall CARTO 3 Systemsee related information
Date Initiated by FirmJune 22, 2020
Create DateAugust 24, 2020
Recall Status1 Terminated 3 on January 06, 2022
Recall NumberZ-2880-2020
Recall Event ID 85910
510(K)NumberK191660 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductCARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Biosense Webster (israel), Ltd.
4, Hatnufah Street
Yoqne'Am Illit Israel
Manufacturer Reason
for Recall		Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.
FDA Determined
Cause 2		Software design
ActionOn 06/22/2020, the firm notified affected US customers via mail of a hospital letter, "URGENT Medical Device Correction", which indicates the following: This product is not being removed from the market and does not need to be returned. A software service pack will be provided by the firm. Your representative will notify you when it is available and will arrange for installation of the service pack. In the meantime, the firm has identified certain mitigations preventing the issue from occurring: If your system is equipped with the VISITAG SURPOINT Module License: - Always enable the VISITAG SURPOINT Module and ensure that the External Processing Unit (EPU) is connected before starting a case. - When using review mode, ensure that the EPU is connected before entering the study and verify that a green connection indication is present on the screen. - When CARTO VISITAG recalculation was performed without the VISITAG SURPOINT Module enabled, recalculate the CARTO VISITAG results with the VISITAG SURPOINT Module by physically reconnecting the EPU, then exit and continue the study and verify that a green connection indication is present on the screen. If your system is not equipped with a VISITAG SURPOINT Module License: - Avoid triggering CARTO VISITAG recalculations as much as possible. - During the procedure consider applying a manual tag for each ablation location by acquiring an ablation point in addition to the CARTO VISITAG Module marking the ablation locations. - If a CARTO VISITAG tag disappears, the CARTO 3 system will still provide an indication of ablation at this location for the manually acquired points. - During offline review of a previous study, be aware that some CARTO VISITAG tags may have disappeared. For next steps, 1. Please review this letter carefully and share it with anyone in your facility that needs to be informed. 2. Please complete, sign, and return the Business Reply Form to the fim via email. The firm notif
DistributionWorldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI *Three (3) U.S. government consignees. The countries of Australia, Austria, Belgium, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Portugal, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQK
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