Events

Device Recall enFlow IV Fluid Warmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Signs Devices, a GE Healthcare Company 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
    59688
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3040-2011
  • 사례 시작날짜
    2011-06-30
  • 사례 출판 날짜
    2011-08-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103330
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • 원인
    Enflow iv fluid warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.
  • 조치
    GE Healthcare sent UMDC Letters/UMDC Confirmation Letters to customers on June 30, 2011. GE Healthcare sent UMDC Letters/UMDC Confirmation Letters on October 24, 2011 reflecting a new recall strategy.

Device

Device Recall enFlow IV Fluid Warmer
  • 모델명 / 제조번호(시리얼번호)
    K060537 D071942 Serial numbers: 00110412 00110497 00111507 00111633 00111718 00111719 00111816 00111835 00110790 00110946 00111686 00111691 00111916 00111764 00111787 00111897 00111939 00112078 00112200 00111880 00111906 00111733 00111664 00111668 00111672 00111673 00111699 00111745 00111749 00111771 00111773 00111786 00111807 00111817 00111832 00111865 00111886 00111891 00111898 00111954 00111975 00111996 00111997 00112042 00112071 00112106 00111703
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the country of Vietnam
  • 제품 설명
    enFlow IV Fluid Warmer Part number 980105VS; || (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) || Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • 제조사 주소
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA