Events

MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray 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-2015-RN-00070-1
  • 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-00070-1
  • 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 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 Healthcare is recommending a system restart that may solve both issues when the software keys are not loaded. Philips Healthcare is providing the following instructions to identify the defects: If the license key for spectral filter is not loaded: once an EPX with half-dose is selected the incomplete dose reduction can be noticed via the actual skin dose (rate) displayed on the image monitor and the actual filter selection is displayed on the examination monitor. If the license key for full table tilt range is not loaded: The tilt movement stops at -20 degrees. This can be observed while preparing the room. Philips Healthcare released a software update and organising Philips field service engineers to install Software release R6.1.3 which addresses the non-loading of the Software license keys. This action has been closed-out on 08/08/2016.

Device

MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray system)
  • 모델명 / 제조번호(시리얼번호)
    MultiDiagnost Eleva Flat Detector (FD) System(Diagnostic fluoroscopic digital X-ray system)Product Code: 708037ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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