Merge OrthoCase with software versions 3.7.3 and earlier (a picture archiving and communications system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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
    RC-2016-RN-00869-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-30
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    When using the perpendicular line tool, there is an option to 'snap' the lines together, which prevents the perpendicular lines from extending past the straight/base line. when a perpendicular line measurement is made and saved in a plan, the line measurement value changes when the plan is reloaded. this is due to when the “snap to line” feature is enabled, it doesn’t apply automatically when the perpendicular line is drawn. it only gets applied when the saved plan is reloaded, so to the user, the measurements look different from what was saved. however, in each case (before/after “snap to line” is applied), the line measurement is accurate.If the line end point is within 20 pixels of the base line, it will adjust its location to snap perfectly to the base line. this may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.This may cause delay in diagnosis or treatment of patient, however the actual measurement of the line is accurate.
  • 조치
    Emergo is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been clsoed-out on 27/02/2017.

Device

Manufacturer