Events

DRX Revolution Mobile X-Ray System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carestream Health Australia Pty 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
    RC-2013-RN-01269-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01269-1
  • 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
    The manufacturer, carestream health inc has received reports of the below incidents:- in the usa, the end cover of the drx revolution mobile x-ray system column was dislodged when it was caught on an interfering object whilst the column was descending.- four occurrences in the usa of a communication failure between pc (host computer) and communication i/o board (cib) resulting in the generator not being reset after a successful exposure and image acquisition. this resulted in an exposure initiated by the user using the hand switch completing without the image being captured.
  • 조치
    Carestream Health is installing a replacement end cap and software update to correct the issues.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd