Events

Device Recall HiSpeed X/i Computed Tomography 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical 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
    54154
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0007-2011
  • 사례 시작날짜
    2009-05-01
  • 사례 출판 날짜
    2010-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87691
  • 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
    It was discovered that the operator console did not have a label affixed in accordance with 21cfr 1010.2 indicating certification to applicable performance standards.
  • 조치
    GE Healthcare will bring customer systems into compliance with 21 CFR by having a GE Healthcare field service representative, who will perform a field corrective action, visit each customer site. This will be carried out via a Field Modification Instruction planned to be released in October 2009 and planned to be completed by February 2010. Additionally, all forward production operator consoles are manufactured so as to comply with 21 CFR and to include a manufacturing check for appropriate labeling.

Device

Device Recall HiSpeed X/i Computed Tomography
  • 모델명 / 제조번호(시리얼번호)
    Console Serial Numbers: 074639HM6, 659297YM6, 695155YM2, 730392YM8, 777756YM8, 789223YM5, 818161YM2, 836965YM4, 836971YM2, 864568YM 1, 869641 YM 1, 530941YM4, 594144YM8, 659292YM7, 678189YM2, 65931 1YM5, 696890YM3, 530873YM9, 659208YM3, 730349YM8, 544504YM4, 766560YM7, 766630YM8, 856398YM3, 474793YM7, 530946YM3, 874664YM6, 813279YM7, 839995YM8, 854095YM7, 869512YM4, 766587YMO, 887561YM9, 840000YM4, 813261 YM5, 717723YM1, 717727YM2, 877979YM5, 808479YMO, 812782YM1, 659200YMO, 766610OYMO, 877971YM2, 730393YM6, and 865531YM8.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, and WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia.
  • 제품 설명
    HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. || The expected usage of this product is to generate head and whole body CT images of human subjects.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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