Biosense Webster, Inc. recalls SMARTABLATE RF System Generator
- Recall date
- June 14, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0210-2018
- FDA classification
- Class II
- Brand / firm
- Biosense Webster, Inc.
- Sold / distributed
- 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.
Why it was recalled
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SMARTABLATE RF System Generator
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