FDAFDA · Alimentos y medicamentos·N.º oficial Z-2880-2020
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
Publicado el 2 de septiembre de 2020 · Inicio del retiro: 22 de junio de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Biosense Webster (israel), Ltd.
- Distribuidor
- 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.
- Lote
- All serial numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Israel
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