Events

Microsoft Amalga UIS 2009 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
    61673
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1702-2012
  • 사례 시작날짜
    2012-04-12
  • 사례 출판 날짜
    2012-06-04
  • 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=108695
  • 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
    Microsoft amalga uis 2009 has an issue with the display of lab results in the lab details window of the lab result viewer. the lab details view does not freeze/pin the row header when the user scroll horizontally.
  • 조치
    Microsoft Corporation Health Solutions Group sent an "URGENT FIELD SAFETY NOTICE" dated April 12, 2012 to all affected customers via e-mail. The letter identifies the product, problem, and actions to be taken by the customers. The firm plans to revise its labeling for Amalga to clarify that the row headers will not be visible as the user scrolls horizontally. Customers were asked to complete and return to the firm a response form via fax at 425-706-7329 or e-mail to vlpigin@microsoft.com.

Device

Microsoft Amalga UIS 2009
  • 모델명 / 제조번호(시리얼번호)
    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), including subsequent R2 release, Service Packs (SP)1, SP2, SP3.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AR, MA, MD, NC, NY, and WA and the country of China.
  • 제품 설명
    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use. || 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