Biosense Webster SMARTABLATE RF System Generator Recall: RF Energy Risk
Biosense Webster recalls SMARTABLATE RF System Generator (M490:006, M490007) due to risk of unintended RF energy delivery if foot pedal near Stereotaxis magnets.
Use caution until it’s fixed
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Contact the company
What happened, in plain English
Biosense Webster is recalling SMARTABLATE RF System Generator models M490006 and M490007 because the foot pedal can deliver radiofrequency energy if placed close to Stereotaxis magnets. This could cause unintended tissue heating during medical procedures. Read more at govinfonow.com/recall/73869-biosense-webster-smartablate-rf-system-generator-recall-rf-energy-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73869-biosense-webster-smartablate-rf-system-generator-recall-rf-energy-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0210-2018
Cite this page
“Biosense Webster SMARTABLATE RF System Generator Recall: RF Energy Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73869-biosense-webster-smartablate-rf-system-generator-recall-rf-energy-risk. Based on FDA recall #Z-0210-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2018%22&limit=1).
Why it’s dangerous
The foot pedal can deliver radiofrequency energy if placed near Stereotaxis magnets, potentially causing unintended tissue heating during medical procedures. This risk occurs when the foot pedal is oriented toward the magnets and in close proximity.
Who’s affected
Medical professionals using the SMARTABLATE RF System Generator for procedures involving Stereotaxis magnets are most at risk. Patients receiving these procedures may also be affected if the device malfunctions.
How to tell if you have this one
Check for product codes M490006 or M490007 on the SMARTABLATE RF System Generator. The device is sold for medical use in the U.S. and Canada.
- Brand
Biosense Webster- Category
Medical device
What to do — step by step
Check Foot Pedal Position
Ensure the foot pedal is not placed near Stereotaxis magnets during procedures.
Where it went and when
Where it was distributed
Distributed in 15 states, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Georgia, Illinois, Indiana, Michigan, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0210-2018 (June 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0210-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.