Devices

Device Recall SMARTABLATE RF Generator System

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
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.
Product Description
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
Biosense Webster, Inc.
1 Event
- Recall of Device Recall SMARTABLATE RF Generator System

Manufacturer

Biosense Webster, Inc.

Manufacturer Address
Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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