Events

Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic system) 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-2012-RN-00890-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-09-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00890-1
  • 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 patient support may move in an unintended manner if the foot switch cover impinges on the foot switch. damage to the foot switch cover can occur when the couch is lowered and the patient support cover presses down on the foot switch cover and bends it. this can lead to the foot switch cover being deformed in a manner that causes the foot switch cover to engage the unload foot switch. this can lead to unintended movement of the patient support, such as intermittent operation of up and down movement or continued movement when the pedal is released.
  • 조치
    Philips Healthcare is providing work around instructions and is planning to replace the sheet metal multi function footswitch.

Device

Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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