Biosense Webster, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0210-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

SMARTABLATE RF System Generator

Product Classification:

Class II

Date Initiated: June 14, 2017

Date Posted: December 13, 2017

Recall Number: Z-0210-2018

Event ID: 77575

Reason for Recall:

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

Status: Terminated

Product Quantity: 185 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated