ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software 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
    2015-03-11
  • 사례 출판 날짜
    2015-03-11
  • 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 exactrac v. 6.X – cone beam computed tomography (cbct) import & alignment software medical device manufacturer, brainlab ag, has issued a medical device safety alert concerning its exactrac v. 6.X – cone beam computed tomography (cbct) import & alignment software [software version: exactrac v. 6.X (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0), in combination with varian truebeam system only]. according to the manufacturer, if a user-defined actively re-reconstructed cbct subvolume is imported into exactrac, exactrac cannot regard the position of this cbct subvolume correctly. if the center of this subvolume differs from the center of the original cbct volume, this leads to an erroneous calculation of patient shifts needed to move the patient to the planned treatment position. if the corresponding calculated shifts and rotations are applied with exactrac, the patient will be positioned incorrectly at the linear accelerator (linac). if not detected by the user, the radiation treatment dose at the linac may be delivered to an unintended target position. if the deviation exceeds clinically acceptable limits, this could result in ineffective treatment, serious patient injury, or even death of the patient. the manufacturer advises users to take the following actions:- with immediate effect, do not use any actively re-reconstructed cbct subvolumes from the varian truebeam system with the brainlab exactrac 6.X cbct import & alignment software module. import exclusively original, not modified, cbct volumes into exactrac to use for patient positioning. continue to verify any exactrac cbct-based correction using the exactrac x-ray verification and/or an external igrt procedure as mandatory. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 march 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Brainlab ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
  • Manufacturer

Manufacturer