Events

Device Recall NeuViz 16 MultiSlice CT Scanner System 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
    73741
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1573-2016
  • 사례 시작날짜
    2016-03-24
  • 사례 출판 날짜
    2016-04-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144838
  • 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 following issues are found in neuviz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) during the filming operation on mx 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be.
  • 조치
    Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.

Device

Device Recall NeuViz 16 MultiSlice CT Scanner System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
  • 제품 설명
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 || a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
  • 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., No. 2 Xiu xiu Street, Hunnan; Sujiatun, Shenyang China
  • Source
    USFDA