Philips MX 16-slice CT systems featured with Lung Nodule Analysis 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-01603-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-12-09
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 formula of doubling time is incorrectly defined in lung nodule analysis (lna). this may result in the wrong calculation result of doubling time, which may lead to misdiagnosis. lna is an optional tool that is only featured on mx 16-slice systems with software version 2.0.
  • 조치
    Philips will upgrade the system software and replace the software discs free of change. Before the software is upgraded, customers are advised not to refer to the parameter of “Doubling Time [day]” in Lung Nodule Analysis, instead refer to the parameter “Growth Rate [%]” for the growth of nodules.

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips MX 16-slice CT systems featured with Lung Nodule AnalysisSerial numbers: 100006, 200019, 200065, 200001, 200021, 200067, 200002, 200022, 200071, 200009, 200023, 200079, 200011, 200026, 200083, 200014, 200029, 200084, 200016, 200035, 200090, 200017, 200059, 200092, 200018, 200062, 200078ARTG Number: 158775
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA