Events

Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Radiation Oncology Systems 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
    20038
  • 사례 시작날짜
    2016-04-18
  • 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
    Autospect pro is a spect reconstruction application residing on the extended brilliance workspace nm workstation. it was found that the software may display incorrect results if the data processed is derived from spect acquisitions using detectors positioned at angles other than 90° or 180° relative to on another. reliance on these results could lead to an incorrect assessment of a patient's myocardial perfusion, in which case the patient may not receive further indicated diagnostic tests or therapy, putting the patient at risk for a subsequent cardiovascular event. many gamma cameras only allow acquisitions at relative 90° or 180°, so this issue cannot occur when reconstructing data obtained with those systems. philips has not received any report of any patient harm associated with this issue.
  • 조치
    Software to be upgraded

Device

Philips AutoSPECT Pro Reconstruction application on Extended Brilliance Workspace

Manufacturer

Philips Radiation Oncology Systems
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA