Events

DigitalDiagnost - EasyUpgrade DR (Diagnostic digital 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-2013-RN-00910-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00910-1
  • 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
    The mirror icon on the bottom of each image could be misinterpreted as a right lead marker for side indication if the image is mirrored within a pacs system.The misinterpretation of the mirror icon to be a patient right side indication could potentially lead to a misdiagnosis.
  • 조치
    Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of the patient or equivalent electronic markers to provide Left/Right indicators, during all x-ray image acquisitions. Philips is advising users that a software and hardware upgrade will be performed to replace the mirror icon. Philips will also provide updated Instructions for Use for the work spot and the system.

Device

DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)system code 712086ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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