Events

MX 16-Slice (Full body CT 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-2013-RN-00849-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00849-1
  • 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 healthcare received a report stating that a doctor received a finger pinch from the table top, which resulted in injury. the injury occurred when the doctor placed their hand at the end of the table top. the operator of the system did not notice that the doctor's finger was positioned at the pinch point when they started the movement of the table top.
  • 조치
    Philips will be providing additional warning labels and instructions to users to prevent this issue from occurring. In the interim, Philips Healthcare is advising users to ensure CT scanner room access is controlled by procedures and policies that identify authorised personnel, and includes that patient or bystanders are to keep hands away from the table top when moving. Philips is advising operators to observe the status of patient or bystander when operating the control panel and CT-Box to control patient table.

Device

MX 16-Slice (Full body CT system)

Manufacturer

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