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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DXX 510(K)s with Product Code = DXX
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