Events

Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T 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-00347-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-04-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00347-1
  • 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
    In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as quenching of the magnet) and at the same time the designed helium ventilation path is impeded. philips has become aware of one instance where this happened in a philips system. investigation found the metal burst disk assembly in the vent path did not perform according to specifications.
  • 조치
    As an interim measure Philips is referring users to follow the relevant sections of the current IFU in the event helium gas escapes into the examination room during a magnet quench; and As a long term correction Philips will schedule an inspection of all MRI systems that may be affected by this issue and where applicable the spare 3” metal burst disk will be replaced during this inspection. Philips advises that planning will be carefully coordinated and where possible this correction will be done during off hours to reduce any disturbance to customers.

Device

Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T
  • 모델명 / 제조번호(시리얼번호)
    Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5TARTG Number: 230064(Philips Electronics Australia - MRI system, full-body, superconducting magnet)
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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