Device Recall DigiView software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Digisonics, 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
    58395
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2180-2011
  • 사례 시작날짜
    2009-01-20
  • 사례 출판 날짜
    2011-05-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-05-31
  • 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
    system, image processing, radiological - Product Code LLZ
  • 원인
    Data from one patient's study had the potential for being put into another patient's report.
  • 조치
    Digisonics notified end users via e-mail January 20, 2009 and January 21, 2009, that Data from one patient's study was being put into another patient's report. The problem occurred when a System bug was found in DigiView Release 3.6.4.4, and higher versions in which under certain circumstances (specific workflow) a failure to switch to a patient's images occurs. Two software patch versions will be made available to sites on or after February 5, 2009, to correct the reported problem. If you have any further questions, please contact Digisonics Customer Support at (800 ) 940-3240.

Device

  • 모델명 / 제조번호(시리얼번호)
    DigiView Rel. 3.6.4.4, 3.6.4.6, and 3.6.5.2.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including States of : OH, NC, LA, TX, CA, MO, NY, MD, MA, DC, IA, AZ, PA, MI, NC, FL, IN, SC, ID, MN, AR, OK, IL, CT, and countries of Canada, Lebanon, and New Zealand.
  • 제품 설명
    Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240. || DigiView is a digital image management and reporting system with an associated clinical database. It provides capture, review, and storage of images together with report creation and data basing.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Digisonics, Inc, 3701 Kirby Dr Ste 930, Houston TX 77098-3922
  • 제조사 모회사 (2017)
  • Source
    USFDA