Events

Device Recall GE Centricity Web Diagnostic (WebDx) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ge Medical Systems Information T 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
    64545
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1782-2017
  • 사례 시작날짜
    2013-02-18
  • 사례 출판 날짜
    2017-04-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116455
  • 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
    It was reported from a complaint that study category labels of "prior" and "baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
  • 조치
    Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue.

Device

Device Recall GE Centricity Web Diagnostic (WebDx)
  • 모델명 / 제조번호(시리얼번호)
    Versions 1.0, 1.1, 2.0, 2.1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Worldwide
  • 제품 설명
    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
  • Manufacturer
    Ge Medical Systems Information T

Manufacturer

Ge Medical Systems Information T
  • 제조사 주소
    Ge Medical Systems Information T, 540 W Northwest Hwy, Barrington IL 60010-3051
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA