SMARTABLATE RF Generator System recall
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all…
Why was SMARTABLATE RF Generator System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all…
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 115 units
- 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.
- Recall date
- June 3, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)