Events

Computerized Tomography Equipment 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Philips And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee División Of Philips Medical Systems (Cleveland) Inc || Philips Healthcare (Suzhou) Co., Ltd || Philips Medical Systems (Cleveland) Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1605-194
  • 사례 연번
    2008EBC-0001540
  • 날짜
    2016-05-05
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer the manufacturer reports that the referenced devices present the following series of drawbacks: 1) cardiac mri - irregular appearance of the contrast in vessels.2) losing annotations on image in cct.3) artifact halo.4) unable to fit z locations in the pre-scan and ct scanner of 4d.5) wrong z annotations in the planned box for coronary / sagittal inspection (see aclient information chart) .6) unintentional change of acquisition time in the scanner rule.7) bolo tracker not it is activated as expected.8) system does not respond when paused.9) unplanned results during multiphase pulmonary series could cause a system collision.10) communication errors between the computer host and the gantry.11) artifact mill of wind with a zone width of 0.67mm. if these situations occur, they could lead to potential adverse events on patients or delays in care.

Device

Computerized Tomography Equipment

Manufacturer

Philips And Neusoft Medical System Co Ltd || Philips Medical System Technologies Ltd. || Dunlee D...
  • Source
    NIDFSINVIMA