Events

Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 McKesson Provider Technologies - 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
    55598
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1974-2010
  • 사례 시작날짜
    2010-04-15
  • 사례 출판 날짜
    2010-07-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91258
  • 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
    computer, diagnostic, programmable - Product Code DQK
  • 원인
    Mckesson has recently discovered that certain horizon cardiology hemo systems were running specific schiller argus-pro pb 1000 firmware versions that might cause a delay in the display of physiological parameters on the horizon cariology hemo real time monitor screen.
  • 조치
    The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.

Device

Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit
  • 모델명 / 제조번호(시리얼번호)
    Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M Serial numbers prefaced with PB-1000: 765.001471, 760.001566, 760.001793, 760.001882, 760.001920, 760.001934, 760.001970, 760.002043, 760.002113, 765.001168, 765.001307, 765.001520, 765.001553, 765.001599, 765.001609, 765.001510, 765.001632, 765.00165, 765.003014, 760.001320, 760,001552, 760.001555, 760,001920, 760.002107, 765.001224, 765.001306, 765.001608.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .
  • 제품 설명
    Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. || Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. || A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group

Manufacturer

McKesson Provider Technologies - Medical Imaging Group
  • 제조사 주소
    McKesson Provider Technologies - Medical Imaging Group, 1639 State Rt 10 Ste 100, Parsippany NJ 07054-4506
  • 제조사 모회사 (2017)
    Mckesson Corporation
  • Source
    USFDA