iPlan RT Dose version 4.1 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Brainlab AG 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
    2012-06-22
  • 사례 출판 날짜
    2012-06-22
  • 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: brainlab iplan rt dose version 4.1 medical device manufacturer, brainlab ag issued a medical device safety alert concerning radiation therapy treatment planning system iplan rt dose version 4.1 (v. 4.1.0, 4.1.1 and 4.1.2). according to brainlab, iplan rt dose 4.1 might position the isocenters and rt structures in the dicom ct image files incorrectly if all of the following conditions are met: two or more ct image sets have the same “frame of reference” (same coordinate system). the selected “reference set” and “alignment set” in iplan rt are different ct image sets, but have the same “frame of reference”. for the “reference set” and “alignment set” the used scanner settings differed at least in one of the following parameters: - pixel size - scan range (number of ct images and position) - slice thickness/distance or - matrix size the dicom “full export” - this is not the default “r& v export” - is used to export to a non-brainlab system (e.G. to another radiation therapy treatment planning system). brainlab explained that if all of the conditions above are met, the treatment dose might be delivered to a region different from the planned one. if the deviation would exceed clinically acceptable limits and at the same time be small enough to remain undetected, this could result in serious patient injury and/or ineffective treatment. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Brainlab iPlan RT Dose version 4.1
  • Manufacturer

Manufacturer