Events

IntelliSpace PACS 4.4 (Picture archiving and communication system) 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-2013-RN-01072-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01072-1
  • 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
    Philips healthcare has become aware of a potential problem with the philips intellispace pacs system. there is a software issue which in certain circumstances could result in the unintended deletion of images sent to the intellispace pacs 4.4 before they are available for access by system users. timing of images being received by the pacs varies based on study size or modality configuration. if additional images are received into the study input folder as the input folder is being deleted, those images are not saved and can result in missing images.
  • 조치
    Philips is providing temporary workaround instructions to mitigate the failure mode occurring. Philips is developing a software update that corrects this issue. It is anticipated this update will be available before the end of October 2013.

Device

IntelliSpace PACS 4.4 (Picture archiving and communication system)

Manufacturer

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