Events

DuraDiagnost X-ray systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2016-RN-00925-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00925-1
  • 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
    Duradiagnost systems provide an audible exposure termination signal (beep) through the speaker integrated into the monitor. however, buttons or keys on the monitor allow the user to turn the volume setting down to “0”, in which case the beep will not be heard at the conclusion of an exposure. note that the current volume setting is displayed when the buttons or keys are depressed. if the monitor volume is set to “0”, the absence of an audible exposure termination signal may lead the operator to assume that an exposure was not performed correctly and therefore unnecessarily repeat the patient exposure.
  • 조치
    Philips is advising users to check the volume of the monitor to ensure it is not set to '0'. Philips will be implementing a software upgrade as a permanent correction.

Device

DuraDiagnost X-ray systems

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA