Events

MultiDiagnost Eleva II/TV Systems 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-2015-RN-00069-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00069-1
  • 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 has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 cfr 1003.2(b)(1). in the md eleva system, software license keys are used to enable particular functionality. in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: - the license key for spectral filter- the license key for full table tilt range.
  • 조치
    Philips is providing end users with instruction on how to identify if the drivers are not loading correctly. A Philips Field Service Engineer will install a software update to correct this issue. This action has been closed-out on 31/05/2016.

Device

MultiDiagnost Eleva II/TV Systems

Manufacturer

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