Events

Device Recall Magellan Robotic 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
    70847
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1449-2015
  • 사례 시작날짜
    2015-03-18
  • 사례 출판 날짜
    2015-04-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135134
  • 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
    Based on investigation of two complaint incidents, all hansen medical magellan robotic system (model no. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. retraction of catheter may not stop when equipment button is released.
  • 조치
    Hansen Medical sent an Urgent Notice - Field Safety Notice dated March 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you review the information in pages 1 and 2 with Hansen Medical personnel and acknowledge your understanding by signing the Field Safety Notice Training Form on page 3. If you need any further information regarding this issue, please do not hesitate to contact me via telephone at 650-404-2784.

Device

Device Recall Magellan Robotic System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
  • 제품 설명
    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
  • 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