OCTOPUS 900 PRO 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 INNOVA MEDICAL OPHTHALMICS 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
    51949
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-11-08
  • 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
    Due to a software error the background illumination of the cupola may not be switched on at the start of an examination. results will appear to be "better" than the actual ones. due to the software error an examination taken with the dynamic or normal strategy may show a huge overshoot in the cumulated defect (bebie) curve and the corresponding visual field indices (md and ms). the effect is less obvious with the top strategy. if these results are considered in isolation from the results of previous visual field examinations or from other examinations (e.G. intraocular pressure measurements or examinations of the optic nerve head) the visual field of the patient may remain untreated.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 7220002 (Lot serial: VARIOUS LOTS); Model Catalog: 7220001 (Lot serial: VARIOUS LOTS)
  • 제품 설명
    OCTOPUS 900 PRO
  • Manufacturer

Manufacturer