Device Recall AFX Endovascular AAA System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Endologix 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
    76106
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1054-2017
  • 사례 시작날짜
    2016-12-27
  • 사례 출판 날짜
    2017-01-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-04-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • 원인
    Endologix updated the instructions for use (ifu) and implemented modifications to the afx endovascular aaa system (afx system).
  • 조치
    A Dear Physician letter dated 6/2/15 was sent to customers to inform them of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update on the clinical programs and commercial experience (i.e., post-market surveillance). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports for the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. On 12/27/2016 a Dear Physician letter provides important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers that a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. Customers with any questions are instructed to contact their Endologix representative.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • 제품 설명
    AFX Endovascular AAA System, Endoleak Type IIIB || Common Name: AFX Bifurcated and Accessory Stent Grafts || Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
  • Manufacturer

Manufacturer

  • 제조사 주소
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • 제조사 모회사 (2017)
  • Source
    USFDA