Events

Device Recall Microsoft Amalga Unified Intelligence System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microsoft Corporation Health Solutions 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
    60890
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1082-2012
  • 사례 시작날짜
    2012-01-04
  • 사례 출판 날짜
    2012-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106729
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    Healthcare providers reported that when sharing a single browser session on amalga web, patient a's data can be displayed under patient b's name.
  • 조치
    Microsoft Corporation sent an "Urgent Field Safety Notice" letter dated January 5, 2012 by email to all affected customers. The letter described the product, problem, and actions to be taken by the customers. If you have any questions about this corrective action program, please contact Microsoft Corporation at 425-882-8080.

Device

Device Recall Microsoft Amalga Unified Intelligence System
  • 모델명 / 제조번호(시리얼번호)
    Software Version: R2 SP2, RTM, R2 SP3
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of California, China, Kentucky, North Carolina, Wisconsin and country of Switzerland.
  • 제품 설명
    Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 || Product Usage: || Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs.
  • Manufacturer
    Microsoft Corporation Health Solutions Group

Manufacturer

Microsoft Corporation Health Solutions Group
  • 제조사 주소
    Microsoft Corporation Health Solutions Group, 14870 NE 31st Way, Redmond WA 98052
  • Source
    USFDA