FDAFDA · Food and drugs·Recall number Z-0210-2018
SMARTABLATE RF System Generator
Published December 13, 2017 · Recall initiated: June 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster, Inc.
- Distributor
- 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.
- Lot
- Product Codes M490006, M490007
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.