Events

Device Recall NeuViz 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips And Neusoft Medical Systems Co., Ltd. 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
    48657
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2235-2008
  • 사례 시작날짜
    2007-12-17
  • 사례 출판 날짜
    2008-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71823
  • 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 Scanner - Product Code JAK
  • 원인
    Labeling of patient position on scanned image does not match actual patient orientation.
  • 조치
    On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.

Device

Device Recall NeuViz
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution in US: CO, FL, KY, NC, SC, TN, and TX.
  • 제품 설명
    NeuViz Dual series computed Tomography Scanner System, X-Ray System || The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
  • Manufacturer
    Philips And Neusoft Medical Systems Co., Ltd.

Manufacturer

Philips And Neusoft Medical Systems Co., Ltd.
  • 제조사 주소
    Philips And Neusoft Medical Systems Co., Ltd., Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA