Events

Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480) 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-01082-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01082-1
  • 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
    In 2d and filming function, when image is zoomed and saved as derived dicom format, the measurement on new created image is incorrect. this issue only occurs on mx16 systems with software version v2.0.0.21479, including mx16 evo2 systems and mx 16 systems upgraded to mx16 evo2 using the mx16 idose4 upgrade kit.Image with incorrect measurement value may be used to guide clinical procedures where measurement is critical. this may lead to misdiagnosis.
  • 조치
    An initial workaround is provided for users in the Customer Letter. Philips will release Field Change Order (FCO) 72800646 to upgrade the software free of change. A Philips Field Engineer will contact users to schedule this correction. This action has been closed-out on 31/08/2016.

Device

Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0....
  • 모델명 / 제조번호(시리얼번호)
    Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)Affected Products: Philips MX 16-slice CT Systems with software version v2.0.0.21479 ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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