Device Recall GE Centricity PACS Workstation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare It 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
    64785
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2579-2016
  • 사례 시작날짜
    2012-11-15
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong ip address of the centricity exam manager. when a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
  • 조치
    GE sent an Urgent Medical Device Correction letter dated November 15, 2012. The software has been modified to correct these defects. The modified software was released and installed in user sites under GE Healthcare FMI #85196.

Device

  • 모델명 / 제조번호(시리얼번호)
    Centricity PACS versions 3.1.1.x through 3.2.1.x
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
  • 제품 설명
    GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System || Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
  • Manufacturer

Manufacturer

  • 제조사 주소
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • 제조사 모회사 (2017)
  • Source
    USFDA