Events

Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP 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-2016-RN-00066-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00066-1
  • 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 identified an issue due to hydrogen embrittlement of fasteners during manufacture of ct systems. it was determined the issue was due to trapped hydrogen introduced into the fastener during electroplating operations performed by a philips supplier. hydrogen embrittled fasteners can crack and fail suddenly when under stress. assessment of these fasteners determined that sufficient mitigations were in place such that a single-point failure did not exist. even should two fasteners fail for the same component, the occurrence of harm was determined to be less than remote. there have been no complaints associated with this issue, and no reports of injury or death.
  • 조치
    Philips will replace the affected service latch fasteners for the units in the field. Philips is advising customers that in the interim, the affected CT systems have been determined to be safe for continued use.

Device

Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems
  • 모델명 / 제조번호(시리얼번호)
    Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP SystemsAffected Models:728306 – Brilliance iCT728311 – Brilliance iCT SP 728326 – Ingenuity CT728321 – Ingenuity Core728323 – Ingenuity Core128728317 – Ingenuity Flex728244 – Brilliance CT BigBore (Radiology)728243 – Brilliance CT BigBore (Oncology)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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