Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body x-ray 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-2016-RN-00340-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-03-23
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    On the affected ct systems and software versions, the issue relates to the auto transfer to the remote devices (such as pacs), where there is a possibility for intermittent failures to send all images/data series automatically. the images remain on the local storage device until manually transferred to the remote device.
  • 조치
    Philips is advising users of affected CT systems to assure that all images are transferred by checking that images are available on any remote devices before images/data series are deleted from local storage device. If there are missing images/data series on remote devices, the user can manually transfer images/data series to remote devices. Philips will be completing a software upgrade as a permanent fix. This action has been closed-out on 23/06/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body x-ray system)ARTG Number: 98868
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA