SMARTABLATE RF System Generator recall
SMARTABLATE RF System Generator
Why was SMARTABLATE RF System Generator recalled?
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
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?
Product Codes M490006, M490007
- Product
- SMARTABLATE RF System Generator
- Recalling firm
- Biosense Webster, Inc.
- Quantity
- 185 units total
- Distribution
- Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.
- Recall date
- December 13, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)