Device Recall Sensei X Robotic Catheter System

  • 모델명 / 제조번호(시리얼번호)
    Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • 제조사 모회사 (2017)
  • Source
    USFDA