Events

McKesson Horizon Medical Imaging 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mckesson Information Solutions LLC 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
    66301
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2318-2013
  • 사례 시작날짜
    2013-09-04
  • 사례 출판 날짜
    2013-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121962
  • 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
    Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
  • 조치
    Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.

Device

McKesson Horizon Medical Imaging
  • 모델명 / 제조번호(시리얼번호)
    Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
  • 제품 설명
    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
  • Manufacturer
    Mckesson Information Solutions LLC

Manufacturer

Mckesson Information Solutions LLC
  • 제조사 주소
    Mckesson Information Solutions LLC, 5995 Winward Plaza, Information Technology Business, Alpharetta GA 30005
  • Source
    USFDA