Events

GE Centricity Ultra Laboratory System 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
    49517
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0472-2009
  • 사례 시작날짜
    2008-09-22
  • 사례 출판 날짜
    2008-12-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73713
  • 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
    Software computer, error: the abnormal result flag is not being sent in the hl7 messages on results that are lower than the normal range. for further information, please telephone ge healthcare integrated it solutions at 800-437-1171.
  • 조치
    GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled "PRODUCT SAFETY NOTIFICATION." The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.

Device

GE Centricity Ultra Laboratory System
  • 모델명 / 제조번호(시리얼번호)
    Software versions 3.3.2.27_P4 and 4.0.1_SP.x
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Globally - United States including the states of New York and Texas; and the country of Canada.
  • 제품 설명
    GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
  • 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