GEMINI TF BIG BORE PET/CT IMAGING SYSTEM - MAIN UNIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 PHILIPS ELECTRONICS LTD. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    43459
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-07-06
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Issue #1: when a single contour is saved in edit mode tumorloc does not save the contour in the correct location. the contour is saved in the location of the same slice where the last contour was drawn for the last region of interest (roi) in the roi list. a misplaced contour then results in a misplaced isocenter or incorrect field size. this occurs when using the save button exit button or sendtolaser button. issue #2: when the region of interest (roi) is displayed on the beam's eye viewer (bev) in outline mode and the roi color is changed the color is changed in the multi-planar projection (mpr) viewers but not the bev viewers. issue #3: tumor loc-created datasets are flipped and incorrectly labeled when non-gated data is loaded along with pulmonary gated data and is used to create intensity projection datasets (mip minip or avgip). if the clinician obtains a clinical intensity projection dataset in a certain manner a dataset can be generated that is flipped left to right. the resulting dataset is flipped and incorrectly labeled left-to-right when displayed in a viewer.Issue #4: duplicate region of interest (roi) or isocenter names can be created in tumor loc. this duplication is only possible when using the copy feature or manually naming a roi with the suffix " copy". this duplication can be created when creating a new isocenter or roi then creating another new isocenter or roi and naming the second isocenter or roi "firstname copy" (either manually or by clicking copy on the first isocenter or roi) where "firstname" is the name of the first isocenter or roi. if the user then selects the first isocenter or roi and clicks copy the resulting copy has the same name as the second isocenter/roi: "firstname copy".

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 4598 001 18561 (Lot serial: 9224); Model Catalog: 4535 679 94741 (Lot serial: 7103)
  • 제품 설명
    GEMINI TF BIG BORE PET/CT IMAGING SYSTEM
  • Manufacturer

Manufacturer

  • 제조사 주소
    MARKHAM
  • 제조사 모회사 (2017)
  • Source
    HC