Events

Ultrasound Q-Station version 3.0 or higher 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-2015-RN-00491-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00491-1
  • 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
    If a user opens a study for review on q-station before its transfer from the ultrasound system cart has completed, measurements from that study (structured report) may be appended to subsequent studies for other patients. as a result, measurements from one patient may be presented in another patient’s study, due to a failure to clear previous patient information when selecting the new study.This hazardous situation will exist only if all of the following events occur: a user performs and completes a study (study a) on the ultrasound system that includes sr (structured report) measurements and initiates the export of study a to q-station (‘manual’, ‘auto’ or ‘send as you scan’).The user opens study a for review on q-station using view/report/export before the transfer of the sr is complete. no reports of misdiagnosis or harm as a result of the data mixing have been received.
  • 조치
    Philips has corrected this issue via software version 3.3.2 and is sending a CD with this latest version of Q-Station to the affected customer, free of charge. This action has been closed-out on 17/08/2016.

Device

Ultrasound Q-Station version 3.0 or higher

Manufacturer

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