Events

Device Recall 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
    70574
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1550-2015
  • 사례 시작날짜
    2015-02-20
  • 사례 출판 날짜
    2015-04-29
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135407
  • 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
    The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
  • 조치
    The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update. If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.

Device

Device Recall 2008T Hemodialysis Machine
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
  • 제품 설명
    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; || 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; || 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP || The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
  • 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