Events

i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 IQ Medical 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-2014-RN-01265-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01265-1
  • 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
    After upgrading the cassini software to version 2.0.0, the cassini patient database may have beencompromised, resulting in patient examination data being linked to the wrong patient.
  • 조치
    Technical support representative will contact affected customers to inspect and, if necessary, to correct the issue. During the restoration process, the Cassini device will be locked and cannot be used. This is estimated to take 1 to 3 hours. Until the database integrity has been ensured, users are advised not to use patient examination data unless verified to be correctly associated with the patient. A software patch is under development (version 2.0.1, expected mid-December) including making a back-up before updating and a database check before and after an update. This action was undertaken prior to consultation with the Therapeutic Goods Administration. This action has been closed out on 29/01/2016.

Device

i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0
  • 모델명 / 제조번호(시리얼번호)
    i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0ARTG Number: 219343 (TBC)
  • Manufacturer
    IQ Medical

Manufacturer

IQ Medical