BRILLIANCE CT BIG BORE 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
    32304
  • 사례 위험등급
    II
  • 사례 시작날짜
    2018-01-05
  • 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
    Philips became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are: issue #1: efov (extended field of view) check message does not display when fov is set >600mm for a paused scan issue #2: prefer "center x/y 0" and "disable result rotation" checkboxes checked automatically when checking the "ct simulation" issue #3: tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed issue #4: tracker scan completed no images were generated issue #5: continuous link plans the clinical scan outside the surview issue #6: applying tilt on first mpr result when the other axial results are unplanned causes change in scan length and number of cycles of scan issue #7: "system is still initializing. please wait." error issue #8: auto locations not functioning as expected issue #9: system ended exam before completion issue #10: system freeze-up after pause is pressed (for french translation please see e-file).

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 728244 (Lot serial: N/A)
  • 제품 설명
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Manufacturer

Manufacturer

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