Events

Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder 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
    49460
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0456-2009
  • 사례 출판 날짜
    2008-12-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73474
  • 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
    Perinatal Monitoring System - Product Code HGM
  • 원인
    Software anomalies in the alert and reminder feature could result in a delay of treatment. when attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.
  • 조치
    The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.

Device

Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder
  • 모델명 / 제조번호(시리얼번호)
    software version 6.80.0 only with Alert and Reminder feature activated
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- state of Ohio.
  • 제품 설명
    GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 || Intended for use as a clinical data management system.
  • 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