Events

Siemens Digital Linear Accelerators of type Primus, ONCOR and ARTISTE 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
    20516
  • 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
    The manufacturer is informing customers about a new bundled software update that will address multiple issues including issues that have already been previously communicated:, 1. prevention of automatic movements in case of significant risk for collision, 2.Re postioning of 160 mlc after motion stop interlock, 3.Restart of control console, 4. support of tractional monitor units for virtual wedge, 5. transfer of user-defined attributes from one session to another, 6. correction of wrong offset calculation in combination with images acquired with ctvision and also with adaptive targeting option, 7. correction of interrupt of cone beam reconstruction, 8. table rotation values for relative setup, 9. correction of wrong in-session resumption in case of 0 (zero) delivered monitor units, 10. unexpected table movement after internal error message on syngo rt therapist, 11.Update of user documentation "physics primer"., 12.Update of addendum for syngo rt therapist and user documentatio.
  • 조치
    Software to be upgraded

Device

Siemens Digital Linear Accelerators of type Primus, ONCOR and ARTISTE
  • 모델명 / 제조번호(시리얼번호)
    Model: 8162815 and 8168754, Affected: , Software version: 12.0.25 or 13.0.65 and 4.2.110 or 4.3.SP
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG