Events

Device Recall Horizon Medical Imaging 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mckesson Medical Immaging 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
    73452
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1182-2016
  • 사례 시작날짜
    2016-02-18
  • 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=144219
  • 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
    Mckesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. this issue may cause incorrect images to be displayed for a patient.
  • 조치
    McKesson sent an Urgent Field Safety Notice dated February 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate actions to take to reduce the risk to patient All customers receiving this safety notice must contact McKesson Support as soon as possible at 1-800-663-2533 US/Canada and International Toll Free Radiology - 00 800 626 20009: 1) To acknowledge that they have read and understood this Field Safety Notice And 2) Arrange installation of software update/upgrade. This notice should be distributed to all personnel within your organization who need to be aware of this issue and the required actions, and alert other affiliated parties that are affected by this Field Safety Notice. For further questions, please call (404) 338-3556

Device

Device Recall Horizon Medical Imaging
  • 모델명 / 제조번호(시리얼번호)
    McKesson Radiology Versions- 12.1.1, 12.0; Horizon Medical Imaging Versions -11.9, 11.8, 11.7, 11.6, 11.5.2, 11.5.1,11.0.8, 5.0, 4.6.1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY., and the countries of : Guam, Great Britain, France, Canada, Ireland and Australia
  • 제품 설명
    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
  • Manufacturer
    Mckesson Medical Immaging

Manufacturer

Mckesson Medical Immaging
  • 제조사 주소
    Mckesson Medical Immaging, Suite 130-10711 Cambie Road, Richmond Canada British Columbia
  • Source
    USFDA