Events

Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SP 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-2013-RN-00555-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00555-1
  • 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
    The stated tolerance in the instructions for use manual for the recorded scanner output (ctdivol) that is used to approximate patient dose does not accurately represent all systems. on some systems, the measured ctdivol value may fall outside of these stated tolerances. in a worst case scenario, there is the potential for the delivered dose to exceed the reported dose by an amount almost equivalent of a rescan.
  • 조치
    Philips is providing their customers with additional information that clarifies published specifications and correlation of CTDIvol value measurement.

Device

Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 1...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SPMultiple product codes affectedARTG Number: 98868Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore Multiple product codes affectedARTG Number: 118077Precedence SPECT/CTMultiple product codes affectedARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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