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Biosense Webster (israel), Ltd. recalls CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is cat
Recalled September 2, 2020 · FDA recall Z-2880-2020 · Biosense Webster (israel)
Hazard
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 Class II
Units
N/A
Sold at
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 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.
Description
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.
Product
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 procedure, Product Number: -5400-00, UDI: 10846835000870
Manufacturer(s)
Biosense Webster (israel), Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →