Events

Device Recall Fresenius 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
    59483
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3083-2011
  • 사례 시작날짜
    2011-05-04
  • 사례 출판 날짜
    2011-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102875
  • 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
    Hemodialysis system for home use - Product Code ONW
  • 원인
    Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k).
  • 조치
    Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was notified of the retrofit that would be done to their machines. The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit. Please return the receipt for confirmation that you have received this notice. Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.

Device

Device Recall Fresenius
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines
  • 제품 설명
    Fresenius 2008K@home || The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
  • 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