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U.S. Department of Health and Human Services

Class 2 Device Recall Sensei X Robotic Catheter System

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  Class 2 Device Recall Sensei X Robotic Catheter System see related information
Date Initiated by Firm December 04, 2014
Date Posted December 30, 2014
Recall Status1 Terminated 3 on September 03, 2015
Recall Number Z-0896-2015
Recall Event ID 69855
510(K)Number K052480  K073225  K091808  K102168  K141822  
Product Classification System, catheter control, steerable - Product Code DXX
Product Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.

Product Usage:
The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
Code Information Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
Recalling Firm/
Manufacturer		 Hansen Medical Inc
800 E Middlefield Rd
Mountain View CA 94043-4030
For Additional Information Contact Kate Whitin Lee
650-404-5841
Manufacturer Reason
for Recall		 The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user.
FDA Determined
Cause 2		 Device Design
Action Hansen Medical sent an Urgent Notice - Field Safety Notice letters to US customers on December 4, 2014 via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax back the attached form to Hansen medical at 650-404-2773. For further information call 650-404-5841.
Quantity in Commerce 59 USA, 40 OUS
Distribution Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
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.
510(K) Database 510(K)s with Product Code = DXX and Original Applicant = HANSEN MEDICAL, INC.
510(K)s with Product Code = DXX and Original Applicant = HANSON MEDICAL, INC.
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