Events

Device Recall Sensei X Robotic Catheter System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hansen Medical Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    69855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0896-2015
  • 사례 시작날짜
    2014-12-04
  • 사례 출판 날짜
    2014-12-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131725
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, catheter control, steerable - Product Code DXX
  • 원인
    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.
  • 조치
    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.

Device

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
    Cardiovascular Devices
  • 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
    Hansen Medical Inc

Manufacturer

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