Recall Z-2880-2020 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster (israel), Ltd.
CARTO 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 proce
| Date | Jun 22, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | On 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 VISITA |
| Distribution | Worldwide 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 cou |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories Biosense Webster, Inc., Jul 20, 2019 |