Events

Siemens Biograph TruePoint with PET syngo 6.7.x software AND Biograph mCT and mCT Flow systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Medical Solutions USA Inc 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
    20091
  • 사례 시작날짜
    2016-05-03
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    It has become aware, through customer complaint process, that utilizing a phantom other than the siemens solid germanium-68 phantoms may impact the calibration factor values generated during the pet quality control procedure. depending on the type of uniform phantom utilized to perform the pet quality control, the pet calibration factor may be biased due to the system using a specific mu-value of 0.1 cm-1 which is based on the siemens solid germanium-68 phantom. the system will use this default mu-value, regardless of the actual mu-value of the phantom utilized for pet quality control; this may cause a variation in the quantification of the attenuation corrected pet images.
  • 조치
    Manufacturer to issue advice regarding use

Device

Siemens Biograph TruePoint with PET syngo 6.7.x software AND Biograph mCT and mCT Flow systems

Manufacturer

Siemens Medical Solutions USA Inc