Events

BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16 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-00049-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00049-1
  • 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 an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.
  • 조치
    Philips is directing users to the warnings outlined in the IFU for BrighView regarding collimator exchange. Philips is advising customers to stay clear of moving parts during collimator exchange, other than the interaction required to dock/undock collimator carts with the system. It is recommended that the technologist keep their feet out from under the collimator carts while docking / undocking them with the camera. It is further recommended that the technologist observe the system during collimator exchange, and press an E-stop button if something occurs that is unexpected / not as described in the IFU. Philips is updating Preventative Maintenance Procedures to check for and correct any misalignment and/or loose parts associated with collimator exchange.

Device

BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
  • 모델명 / 제조번호(시리얼번호)
    BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16Product Number - 8823500 Precedence 16Product Number - 882351 Precedence 6 SliceProduct Number - 882478 BrightView X Product Number - 882480 BrightView SPECTProduct Number - 882482 BrightView XCTARTG Number: 117440 (Philips Electronics Australia Ltd - SPECT/CT diagnostic imaging system)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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