Events

Philips Ingenuity Core (728321) 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-00312-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00312-1
  • 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 has identified systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that:- prevents system access; or - a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or- during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real timeto date, there have been no reports of patient harm as a result of this issue.
  • 조치
    Philips are advising that they will be contacting users to arrange an appointment for a Field Service Engineer to correct the software on any potentially impacted systems

Device

Philips Ingenuity Core (728321)
  • 모델명 / 제조번호(시리얼번호)
    Philips Ingenuity Core (728321)Serial Numbers: 333166, 333170, 333171, 333173-333181, 333184 ARTG Number: 98868(Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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