Events

GE Healthcare STe (16 slice) System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, 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
    57193
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0944-2011
  • 사례 시작날짜
    2010-10-27
  • 사례 출판 날짜
    2011-02-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95567
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • 원인
    Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain ctdi adjustment factors used for the manual calculation from the technical reference manual (trm) are incorrect. ctdi100 aperture adjustment factors for 4x0.625 mode contain incorrect values. this issue may lead to inaccurate ctdi manual calculation. the results of the diffe.
  • 조치
    An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.

Device

GE Healthcare STe (16 slice) System
  • 모델명 / 제조번호(시리얼번호)
    Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. || Head and whole body X-ray computed tomography applications.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA