Device Recall NeuViz 128 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 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
    75383
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0876-2017
  • 사례 시작날짜
    2016-08-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-01-04
  • 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, x-ray, tomography, computed - Product Code JAK
  • 원인
    The firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. the system must be powered down and restarted to clear the interruption error before scanning can resume.
  • 조치
    Neusoft Medical Systems Co. Ltd. planned action to bring into compliance. 1.Affected Customers will be notified by letter to provide them a description of the affected device, instructions for using the device prior to correction, hazards associated with the defect, and a statement of corrective actions to be taken at no cost to the owner. 2.Field Service Engineers will visit owner sites to install a software update which resolves the defect. 3.Corrections will be made at no cost to the owner 4.Corrections will be completed by May 11, 2017. CDRH approves the CAP subject to the following conditions: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call (281) 453-1205.

Device

  • 모델명 / 제조번호(시리얼번호)
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    NeuViz 128 Multi-slice CT Scanner System with || software version 1.0.7.4038+P06 or previous version
  • Manufacturer

Manufacturer

  • 제조사 주소
    Neusoft Medical Systems Co., Ltd., NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang China
  • Source
    USFDA