Events

Siemens syngo RT Therapist COHERENCE RTT Application Software 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens AG 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
    20518
  • 사례 시작날짜
    2016-08-17
  • 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
    New software update that addresses multiple issues including an issue communicated earlier:, 1. incorrect isocenter assignment when using multiple treatment plans with different isocenters based on one single planning ct and when a cbct has been acquired for each isocenter, 2.When auto field-sequencing (afs) is selected the pause is no longer present when treating a plan containing at least two beams with different isocentric table angles, 3. table movement due to different isocenters in imaging beams and treatment beams, 4. reference image has been associated to the wrong patient, 5.Incorrect calculated isocenter shift when using late resumption after interruption after beam 1 has been completed, 6.Multiple isocenter in session resumption f1 abort workflow is incorrect, 7. irrevocable assignment of the first reference 2d image, 8. after reverting plan changes in ois mosaiq changes performed on rt therapisttm become inactive.
  • 조치
    Software to be upgraded

Device

Siemens syngo RT Therapist COHERENCE RTT Application Software
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: , Software version: 4.2.110 or 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.3.1_MR2 in combination with Oncology Information System ARIA (by VARIAN) or MOSAIQ (by ELEKTA Inc.)
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG