Commercial Name: CT Scanning System / Ingenuity CT. Technical name: CT Scanner / Computerized Tomography Scanner. ANVISA registration number: 10216710191. Class of risk: III - High Risk. Affected Models: Brilliance CT 6-Slice / Brilliance CT 64-Slice / Brilliance iCT / Brilliance iCT / Brilliance iCT / Brilliance CT 16-Slice / Ingenuity CT / Ingenuity Flex. Series Affected: See below 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V 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
    2021
  • 날짜
    2016-09-13
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    The Radiologist or physician should be aware of the fact that if they do not recognize the CT number deviation and the image artifacts resemble the patient's history, in the most severe cases, this problem can lead to misdiagnosis. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • 원인
    When performing skull examinations in high resolution, the reconstructed images may exhibit degraded quality, which is manifested as: - lack of image uniformity; - deviation in ct number, greater than 5 units of hounsfield; - reduction of gray / white matter differentiation. the problem is more pronounced in high resolution mode. philips offers reference protocols for pediatric exams which are factory set for high resolution by default. for skull exams in adults, there is a factory reference protocol, set to normal resolution, which is not affected by the problem.
  • 조치
    Field Action Code FCO72800666 triggered under the responsibility of the company Philips Medical Systems Ltda. Field Correction: Software update.

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