Events

Device Recall NeuViz 64 Multislice CT Scanner System 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
    77608
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3044-2017
  • 사례 시작날짜
    2017-05-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156762
  • 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
    Software defect.
  • 조치
    Neusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release.

Device

Device Recall NeuViz 64 Multislice CT Scanner System
  • 모델명 / 제조번호(시리얼번호)
    NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide distribution
  • 제품 설명
    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: || NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, || NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version || Product Usage: || The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
  • Manufacturer
    Neusoft Medical Systems Co., Ltd.

Manufacturer

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