Skip to content
Recall Observatory FDA recall evidence

Device product

SMARTABLATE RF System Generator

Z-0210-2018

June 14, 2017

Class II

Product summary

Firm
Biosense Webster, Inc.
Event
Event 77575
Status
Terminated
Classification
Class II
Quantity
185 units total
Official record key
device-enforcement:Z-0210-2018

Official wording

Reason: Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.

Code information: Product Codes M490006, M490007

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.