Events

Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic 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-2016-RN-00274-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00274-1
  • 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 healthcare has identified through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. due to the nature of the problem, the user will perceive a gradually increased sluggishness. upon activation of the iu controls an uncontrolled geometry movement can occur. the uncontrolled movements are immediately stopped upon release of the iu controls. all safety measures such as current sensing, 3d model and bodyguard remain intact avoiding serious harm to patient and bystander. a system reboot will restore normal system operation.
  • 조치
    Philips is advising users to regularly restart the system as per the Instructions for Use (IFU) once a day to avoid uncontrolled movements. A software update will be provided as a permanent fix. This action has been closed-out on 26/05/2017.

Device

Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper with software release FD R8.1.16(Fluoroscopic angiographic x-ray system)ARTG Number: 175708
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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