Millennium VG, Discovery VH, Varicam 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 General Electric Med Systems LLC 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
    29988
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0012-05
  • 사례 시작날짜
    2004-09-03
  • 사례 출판 날짜
    2004-10-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-07-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, Tomography, Computed, Emission - Product Code KPS
  • 원인
    Ge healthcare received reports of intermittent low ejection fraction (ef) results for muga (multi-gated acquisitions) studies on millennium vg systems. this issue can occasionally lead to distortions in the volume curve in some muga studies, and result in calculated ef values lower (never higher) than actual values. a low ef value could lead to a physician decision to stop needed treatment.
  • 조치
    A letter dated August 5, 2004 was released to customers describing the issue and recommending that users pay special attention to any volume curve which appears to be abnormal or any EF values that appear to be lower than expected, and not to rely soley on this value for diagnosis purposes until they recieve the SW patch. A SW patch will be distributed shortly to all affected systems.

Device

  • 모델명 / 제조번호(시리얼번호)
    Each unit has a unique serial code. All serial numbers are being recalled.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide throughout the United States and worldwide.
  • 제품 설명
    Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
  • Manufacturer

Manufacturer

  • 제조사 주소
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA