Events

Revision K Actuator Test Boards 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Medical Care Holdings, 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
    68042
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1619-2014
  • 사례 시작날짜
    2014-04-25
  • 사례 출판 날짜
    2014-05-13
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126881
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 원인
    2008-series hemodialysis machines with revision k actuator test boards may fail to detect a disconnected ultrafiltration (uf) pump.
  • 조치
    Fresenius Medical issued Urgent Recall letter issued on 4/25/14 by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected 2008T machines or if they have installed any of the affected replacement boards. If customers have the affected machines or replacement boards, they will be instructed to contact FMC-RTG Technical Service to have the Actuator Test Boards replaced. Contact the FMCNA Technical Service Team at 1-800-227-2572.

Device

Revision K Actuator Test Boards
  • 모델명 / 제조번호(시리얼번호)
    Revision K Actuator Test Boards
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) and the country of Canada.*
  • 제품 설명
    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). || Part Number: 190713 Revision K
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • 제조사 주소
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA