Reported Sep 2, 2020 · Terminated
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is…
Biosense Webster (israel), Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster (israel), Ltd. · 4, Hatnufah Street · Yoqne'Am Illit, N/A · N/A
Is this the product you have?
- CARTO 3 System (Software Version V7.1.80)
- CARTO VISITAG Module - Product UsageFGThe 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
- UDI10846835000870
- Lot codes and dates
- All serial numbers
- Amount recalled
- N/A
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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