Biosense Webster Recalls SMARTABLATE RF System Generator Units
Biosense Webster is recalling 185 SMARTABLATE RF System Generators because they may inadvertently deliver RF energy if the foot pedal is placed near Stereotaxis magnets.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (unintended RF energy delivery) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biosense Webster, Inc. is recalling 185 units of the SMARTABLATE RF System Generator. The recall covers product codes M490006 and M490007. The devices were distributed to 15 U.S. states, including California, Colorado, Georgia, Illinois, Indiana, Michigan, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin. The product was also distributed to Germany, France, Austria, Sweden, Italy, Belgium, Denmark, and Singapore.
The recall was initiated because the generator may inadvertently deliver radiofrequency (RF) energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. This unintended delivery of energy poses a risk of injury to patients or operators during use.
Healthcare facilities and users of the SMARTABLATE RF System Generator should stop using the affected units immediately. Users should contact Biosense Webster, Inc. for instructions on how to return the devices or obtain a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SMARTABLATE RF System Generator
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Codes M490006
- M490007
Distribution
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