Device Recall Sensei X Robotic Catheter System

  • Model / Serial
    Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • Manufacturer Parent Company (2017)
  • Source
    USFDA