Events

Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systems Manufactured beginning May 2009 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-2017-RN-01454-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-12-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01454-1
  • 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
    There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner’s main bearing may come loose. if this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. there is no potential for harm to the patient or operator due to this issue.
  • 조치
    Philips is advising users that they will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. (Reference: Field Correction FCO 72800690)

Device

Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 72833...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systemsManufactured beginning May 2009ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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