Z-0210-2018Class II

SMARTABLATE RF System Generator

Name: Z-0210-2018 SMARTABLATE RF System Generator
Creator: Biosense Webster, Inc.
Published: 2017-06-14
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2017-06-14 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of SMARTABLATE RF System Generator on 2017-06-14. FDA classified it as Class II and gives the reason as "Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0210-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-14
Posted: 2017-12-07
Terminated: 2021-01-11
Recalling firm: Biosense Webster Inc
Product: SMARTABLATE RF System Generator
Product code: LPB Cardiac Ablation Percutaneous Catheter
Reason for recall: Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: All new U.S. and OUS customers, who have purchased the SMARTABLATE" Generator system since the launch of the original field action in March 2015 to the time the IFU was updated in November 2015, will be notified. The previously distributed Field Safety Notification Letter for the SMARTABLATE" Generator (Part Numbers# M490006 and M490007) and customer Acknowledgement Form will be sent to these new customers. Instructions included review the Field Safety Notice carefully, provide the notice to appropriate personnel in facility, ensure the SMARTABLATE System Foot Pedal is not located within the Stereotaxis RMT Lab, complete and return the Acknowledgement Forms, and maintain awareness of the notice.
Quantity in commerce: 185 units total
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.
Product codes and lots: Product Codes M490006, M490007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0210-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07

Product code LPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)