Device Recall Fresenius 2008T Hemodialysis Machine 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
    57851
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1526-2011
  • 사례 시작날짜
    2011-01-19
  • 사례 출판 날짜
    2011-03-04
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-07-08
  • 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
  • 원인
    Cursor on the dialysis screen may disappear and not respond to user input.
  • 조치
    Fresenius Medical Care contacted customers by mailing a Customer Notification letter "Urgent correction FMNCA Model 2008T Hemodialysis Machine" via Certified-Mail, Return Receipt requested on January 19, 2011. The Technical Services department began contacting consignees by telephone on January 13, 2011, to schedule an appointment for installing the electronic board on the 2008T machines at the customers' facilities. For questions call Technical services 1-800-227-2572.

Device

  • 모델명 / 제조번호(시리얼번호)
    Units distributed between Sept 1, 2010 and January 5, 2011. Serial 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  • 유통
    Worldwide Distribution - USA and Canada
  • 제품 설명
    Fresenius 2008T Hemodialysis Machine || Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS || Part Number 190713, 2008T Hemodialysis System with CDX || Part Number 190766, 2008T Hemodialysis System with biBag || The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
  • Manufacturer

Manufacturer

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