Events

Philips Extended Brilliance Workstation (EBW) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems (USA) 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
    13725
  • 사례 시작날짜
    2012-10-29
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    The manufacturer advises that specific versions of ebw software may cause an incorrect display of patient information/annotation and may lead to misinterpretation. specifically:, 1) when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately., 2) in the calcium scoring (cs) protocol, the protocol is switched to mass score but the protocol name remains agatston., 3) spline measurement values do not update when adding control point (cp) and when changing the length of the line., 4) in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct suv values., 5) loading pet images in the ct viewer (ctv) \ quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.
  • 조치
    Software to be upgraded

Device

Philips Extended Brilliance Workstation (EBW)
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Versions 4.0.2, 4.5.2 and 4.5.3 SNs: 12314, 13160, 14329, 14674 ,12142 and 13348
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA