FDA-Device2017-12-13Class II
SMARTABLATE RF System Generator
Biosense Webster, Inc.
Hazard
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Sold states
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.
Affected count
185 units total
Manufactured in
15715 Arrow Hwy, N/A, Irwindale, CA, United States
Products
SMARTABLATE RF System Generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief