ON-BOARD IMAGER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS INC. 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
    131793
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-06-30
  • 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
    An anomaly has been identified in the 3d match environment of obi 1.3 obi 1.4 obi 1.5 truebeam 1.0 and offline review 1.0 - 2.0 when using reference ct datasets which contain a critical number of slices. [note that the 3d match environments of truebeam 1.5 and offline review 2.1 are not affected by this anomaly.] when these reference ct datasets are used to create a reference ct volume in the 3d match environment in a small number of cases the scaling of the ct volume will be incorrect and the ct volume will appear larger - in the slice direction - than it actually should be. if this improperly scaled ct volume is used for 3d matching the cbct volume and patient may be positioned too far superiorly. because of differences in software design obi 1.5 is much more likely to exhibit this behavior than the other products identified.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: OBI (Lot serial: Contact manufacturer.); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: OBI (Lot serial: >10 serial numbers.); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069)
  • 제품 설명
    On Board Imager
  • Manufacturer

Manufacturer