Events

BrightView XCT SPECT/CT 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-2014-RN-01226-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01226-1
  • 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 two issues with the brightview xct spect/ct systems: 1) whilst performing a clinical spect/ ct study on a brightview xct spect/ct systems, the ct portion of the scan may be interrupted and not complete successfully. this problem is not detectable by the user prior to the interruption of the ct acquisition. interruption of the ct acquisition portion of the scan may necessitate a re-scan of the interrupted segment, resulting in overall radiation to the patient being higher than planned. the additional radiation would be less than the amount delivered from a single successful scan of that body segment.2) investigation of generator faults from the field have identified that the ground connection on the x-ray generator cabinet may have been wired incorrectly during installation.
  • 조치
    Philips is advising users of the issue and providing work around instructions should the problem occur. Philips is also updating the XCT generator configuration to increase tube life and implementing a software update.

Device

BrightView XCT SPECT/CT systems
  • 모델명 / 제조번호(시리얼번호)
    BrightView XCT SPECT/CT systemsModel Numbers: 882482 and 882454ARTG number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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