FDAFDA · Food and drugs·Recall number 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
Published September 2, 2020 · Recall initiated: June 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster (israel), Ltd.
- Distributor
- 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.
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.