Events

DigitalDiagnost, Release 4.1/4.1.1 (Digital diagnostic 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-2015-RN-00736-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00736-1
  • 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 system is designed to emit an acoustic signal (beep) upon termination of an exposure. however, if the system has been powered on for more than 12 hours, the system will no longer emit this signal. if this occurs, the system operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure.
  • 조치
    Philips plans to install a software upgrade (i.e., Release 4.1.2) in affected systems, which will eliminate this issue. A Philips Service Engineer will contact affected customers when the Field Action Kit is available to be implemented. Until the system software is upgraded to release 4.1.2 to eliminate the potential loss of the acoustic signal upon termination of an exposure, Philips recommends that the system is rebooted at least every 11 hours. This action has been closed-out on 22/08/2016.

Device

DigitalDiagnost, Release 4.1/4.1.1 (Digital diagnostic X-Ray system)
  • 모델명 / 제조번호(시리얼번호)
    DigitalDiagnost, Release 4.1/4.1.1 (Digital diagnostic X-Ray system)ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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