Device Recall SMARTABLATE RF Generator System

  • Modèle / numéro de série
    SMARTABLATE System Serial No. G4C-0296, G4C-0297, G4C-0272, G4C-0262, G4C-0232, G4C-0090.  System Serial No. G4C-0076, G4C-0195, G4C-0064, G4C-0047, G4C-0159, G4C-0187, G4C-0146, G4C-0140, G4C-0037, G4C-0131, G4C-0031, G0054.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - US Nationwide in the state of: CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.
  • Description du dispositif
    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. || Product Usage: || The 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.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Société-mère du fabricant (2017)
  • Source