syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQ 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 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
    RC-2016-RN-01088-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-23
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Syngo rt therapist is specified in a way that it will always use the plan unique identifier (uid provided by ois mosaiq. if a plan has changed many times and one of the previous changes is reverted, mosaiq will apply the uid of the previous plan, before the change has been made in the past. in this case, from a treatment point of view mosaiq sends a previously used plan uid that may cause the rt therapist to choose an out-dated treatment plan according to the plan uid provided by mosaiq. as a consequence all performed changes on rt therapist, for example setup changes like added pauses or gating flags, will not be active. this behaviour might lead to a collision or a mistreatment.
  • 조치
    Siemens has notified users that from a syngo RT Therapist software point of view, it is not possible to distinguish between correct and incorrect UID provided by MOSAIQ. Therefore no technical solution for this issue can be provided by Siemens. The “RT Therapist Release Notes for MOSAIQ” have been updated with the according information in chapter 10.1. This action has been closed out on 16 June 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQCatalogue Numbers: 8162815 and 8168754ARTG Number: 171515
  • Manufacturer

Manufacturer