Reported Jun 3, 2015 · Terminated
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the…
Biosense Webster, Inc.
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, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
SMARTABLATE RF Generator SystemCatalog No. M490006M490007M4900106and M4900107
- Product UsageThe use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control
- Lot codes and dates
SMARTABLATE System Serial No. G4C-0296G4C-0297G4C-0272G4C-0262G4C-0232G4C-0090. System Serial No. G4C-0076G4C-0195G4C-0064G4C-0047G4C-0159G4C-0187G4C-0146G4C-0140G4C-0037G4C-0131G4C-0031G0054
- Amount recalled
- 115 units
Where it was sold
Why it was recalled
Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.
This product could cause temporary or reversible health problems — stop using it.
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