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U.S. Department of Health and Human Services

Class 2 Device Recall SMARTABLATE System

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  Class 2 Device Recall SMARTABLATE System see related information
Date Initiated by Firm June 14, 2017
Create Date December 07, 2017
Recall Status1 Terminated 3 on January 11, 2021
Recall Number Z-0210-2018
Recall Event ID 77575
PMA Number P990071S017 
Product Classification Cardiac ablation percutaneous catheter - Product Code LPB
Product SMARTABLATE RF System Generator
Code Information Product Codes M490006, M490007
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
Manufacturer Reason
for Recall		 Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPB and Original Applicant = BIOSENSE WEBSTER, INC.
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