Events

ProGrade Rel.1x Systems 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-2018-RN-00135-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-02-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00135-1
  • 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
    If the wifi connection between the skyplate detector and hp transfer point is weak, an image may fail to transfer from the skyplate detector to the system. the image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. to continue, the operator can reset the skyplate detector by removing its batteries, but the acquired image is lost and a re-take is necessary.
  • 조치
    Philips plans to release a new HP firmware to the installed base. In addition the existing Access Point Hardware in the field needs to be patched. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented.

Device

ProGrade Rel.1x Systems

Manufacturer

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