Events

GE Centricity PACS RA1000 Workstation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare Integrated IT Solutions 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
    49458
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0460-2009
  • 사례 출판 날짜
    2008-12-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73472
  • 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
    Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving default display protocols (ddps) which are used to layout images when displaying a study. if the user does not check the study date time of the exam on the image title bar, then they may interpret the curr.
  • 조치
    GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation customers via letter (Product Safety Notification) dated 9/25/08 of the software anomalies resulting in patient safety issues involving the patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa. The letter provided the users with safety instructions to follow until the software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-277-5240.

Device

GE Centricity PACS RA1000 Workstation
  • 모델명 / 제조번호(시리얼번호)
    GE Centricity PACS RA1000 Workstation software versions:  1) Software version 2.1.X (from 2.1.2.1 to 2.1.5.4 inclusive for the patient jacket issue and all 2.1.x releases prior to 2.1.5.1 for the default display protocol issue), and   2) Software version 3.0.X (from 3.0.0.0 to 3.0.3.1 inclusive for the patient jacket issue and all 3.0.x releases prior to 3.0.2 for the default display protocol issue).
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA and countries of Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela.
  • 제품 설명
    GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use 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
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • 제조사 주소
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA