Device Recall 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
    61021
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1191-2012
  • 사례 시작날짜
    2012-01-11
  • 사례 출판 날짜
    2012-03-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-12-12
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    The problem occurs when a user filters the data in amalga datagrid to exclude specific values. if the field specified in the filter criteria contains null values, the filtering will exclude those records as well.
  • 조치
    Microsoft Corporation Health Solutions Group sent a "Urgent Field Safety Notice" email dated January 19, 2012, to all affected customers. Notification of customers in China is still pending due to the Chinese New Year Holiday. Customers were instructed to : 1. If the user notices varying row counts or inconsistent values in a given column and they are using the exclude filter, they may have to look for alternative ways to filter the data that do not use the above mentioned filter conditions. 2. To avoid the indicated issue in your implementation there are two steps to be taken: a. Ensure that all parsers are inserting empty strings () rather than NULL when ingesting data into the system and b. Identify all Baseview definitions (i.e. the sql view that a baseview is accessing) that include an outer join and update those definitions to include the ISNULL replacement function [e.g. ISNULL( column_name, )] on any columns which may return NULL due to a non-matching row in the outer join tab As of January 23, 2012 The firm's members of Services Team have spoken by phone with representative of every customer. Customers should call 425-882-8080 for any questions about this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    2009; R2; R2 SP1; R2 SP2, R2 SP3, RTM.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of AR, CA, KY, HI, FL, MA, MD, MN, NC, NJ, NY, WA, WI and countries China, Switzerland, and United Kingdom.
  • 제품 설명
    Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), 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

Manufacturer

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