MYLA server HP Proliant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 bioMerieux, 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
    71049
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1621-2015
  • 사례 시작날짜
    2015-04-14
  • 사례 출판 날짜
    2015-05-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-12-13
  • 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
    unknown device name - Product Code N/A
  • 원인
    The myla¿ server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. the problem occurs in high volume settings. the myla server slows down and will stop processing completely if any task requires more than 5 minutes to complete. the server then fails to reboot and requires service, provided remotely or on-site.
  • 조치
    Consignees were notified electronically on April 14, 2015 and letter via FedEx on 04/20/2015.

Device

  • 모델명 / 제조번호(시리얼번호)
    Ref. #415603 and 411402
  • 유통
    Worldwide Distribution-Algeria, Argentina, Australia, Austria, Brazil Canada, Chile China, Colombia, Czech Republic, France Germany , Greece, Hungary, India, Italy Japan, Korea, Mexico, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Angola, Armenia, Kocaeli, Bahrain, Bangladesh, Republic of Belarus, Benin, Bolivia, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Germany Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Georgia, Guam, Guatemala, Guinea, Honduras, Indonesia, Iran, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Morocco, Portugal, Myanmar, Managua, Niger, Nigeria, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Kingdom of Saudi Arabia, Senegal, Slovakia, Sri Lanka, Tanzania, Togo, Tunisia, Ukraine, UAE, Uraguay, Venezuela, Vietnam, Yemen and Zimbabwe.
  • 제품 설명
    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. || MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).
  • Manufacturer

Manufacturer

  • 제조사 주소
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • 제조사 모회사 (2017)
  • Source
    USFDA