Events

DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1 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-2012-RN-01208-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-12-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01208-1
  • 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 previously notified owners of affected digitaldiagnost systems that software release 2.1.3 would be installed on the systems to modify the appearance of a mirror icon. however, software release 2.1.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side if an image is rotated.Software release 2.1.4 addresses both the original & new issue, & it will be installed on affected systems in place of release 2.1.3. if software release 2.1.3 has already been installed on a system, it will be replaced with release 2.1.4.With digitaldiagnost r 2.0.2 a mirrored “r in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. when such an image is mirrored back inside the pacs system, an unmirrored “r in a circle” appears in the lower left corner. this can be mistaken for a “right patient side” marker, although this can appear on the left patient side.
  • 조치
    Philips Healthcare will be installing a software update to address the identified issue.

Device

DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1
  • 모델명 / 제조번호(시리얼번호)
    DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1All products with software release 2.0.2 and 2.0.2SP1ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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