Events

Device Recall McKesson Radiology (MR) Picture Archive Communication System (PACS) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mckesson Medical Imaging Group 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
    75194
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2872-2016
  • 사례 시작날짜
    2016-07-12
  • 사례 출판 날짜
    2016-09-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149631
  • 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
    The stat priority icon was not displayed in the study list when the study was opened.
  • 조치
    McKesson sent an Urgent Field Safety Notice on July 12, 2016 to customers with potentially affected software versions. The letter requested that they contact McKesson to acknowledge that they read and understood the Field Safety Notice and to arrange installation of software update/upgrade. Customers with questions were instructed call the McKesson Support department and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.

Device

Device Recall McKesson Radiology (MR) Picture Archive Communication System (PACS)
  • 모델명 / 제조번호(시리얼번호)
    McKesson Radiology versions 12.1.1 and 12.2
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland
  • 제품 설명
    McKesson Radiology, versions 12.1.1 and 12.2 || McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
  • Manufacturer
    Mckesson Medical Imaging Group

Manufacturer

Mckesson Medical Imaging Group
  • 제조사 주소
    Mckesson Medical Imaging Group, 10711 Cambie Rdsuite 130, Richmond Canada British Columbia
  • Source
    USFDA