Device product
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.
Z-1691-2015
Product summary
- Event
- Event 70772
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115 units
- Official record key
device-enforcement:Z-1691-2015
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.