Events

Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit 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-2017-RN-00210-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-02-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00210-1
  • 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
    It has been identified that the intended use statement listed in the instructions for use (ifu) is stated incorrectly. a revision of the ifu with amendments (specifically regarding the functional capabilities of the system) will be released. the amended intended use in the ifu is as follows:brightview xct is a gamma camera for single photon emission computed tomography (spect) and integrates with an attenuation device consisting of flat panel x-ray imaging components. brightview xct produces non-attenuation corrected spect images and attenuation corrected spect images with x-ray transmission data that may also be used for scatter correction. the nuclear medical images and brightview xct images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localisation of the nuclear medicine data. the brightview xct imaging system should be used only by trained healthcare professionals.
  • 조치
    Philips is advising users to be aware of the updated "Intended Use Statement" highlighted in the Customer Information Letter Users are further advised to continue using the system according to their training.

Device

Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit
  • 모델명 / 제조번호(시리얼번호)
    Philips BrightView XCT and Philips BrightView X to XCT Upgrade KitModel Numbers: 882482 and 882454All software versionsARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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