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Biosense Webster, Inc. recalls SMARTABLATE RF System Generator
Recalled December 13, 2017 · FDA recall Z-0210-2018 · Biosense Webster
Hazard
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. · FDA Class II
Units
185 units total
Sold at
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.
Description
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Product
SMARTABLATE RF System Generator
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →