Events

Device Recall FreeStyle CoPilot 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Diabetes Care, 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
    33317
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1594-05
  • 사례 시작날짜
    2005-08-30
  • 사례 출판 날짜
    2005-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-05-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41687
  • 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
    Glucose Dehydrogenase, Glucose - Product Code LFR
  • 원인
    Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
  • 조치
    On 8/30/05, the firm initiated the recall and its notification was via web postings and phone calls requesting discontinuation of the FreeStyle CoPilot from the website. A follow-up letter will be sent to registered users advising them of the issues and instructing them to not use CoPilot.

Device

Device Recall FreeStyle CoPilot
  • 모델명 / 제조번호(시리얼번호)
    N/A. Product is a software package.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Software, distributed from website via clicking through an agrement to use only for informational purposes, and not as a substitute for professional medical advice treatment or diagnosis.
  • 제품 설명
    FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • 제조사 주소
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA