Somatom Definition FORCE with VA50A, VA50A_SP2 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Siemens. 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
  • 날짜
    2016-04-06
  • 사례 출판 날짜
    2016-04-06
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: somatom definition force with va50a, va50a_sp2 the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning somatom definition force with va50a, va50a_sp2, manufactured by siemens. [material number: 10742326]. the manufacturer recently detected that the use of the neonate head with pediatric kernel hp38, a special image reconstruction programme for ct images, could result in artefacts and furthermore in misdiagnosis, as any or delayed medical treatment within the skull is a surgical and time critical event. according to the manufacturer, this arithmetic error within neonate head with pediatric kernel hp38 is not affecting any other kernels and reconstruction modes. as the reconstruction of images uses the raw data in any case, no additional dose or scan with additional dose has to be applied to the patient. in any case of uncertainty, users are advised to use additional and alternative diagnostic systems before they start the medical treatment. the manufacturer is advising users not to use neonate head with pediatric kernel hp38 anymore until they are informed about the corrective actions to improve this behaviour. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-28-march-to-01-april if you are in possession of the affected products, please contact your supplier for necessary actions posted on 6 april 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: SOMATOM Definition FORCE with VA50A, VA50A_SP2
  • Manufacturer

Manufacturer