Events

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2013-RN-00585-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-06-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00585-1
  • 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
    It has come to the attention of siemens that one of their customers used film mode for image acquisition although it was not correctly calibrated, resulting in an overdose to several patients. film mode is a separate beam (dose set 8) and needs to be calibrated and verified prior to being used.
  • 조치
    Siemens is providing additional calibration procedures and asking customers to make sure it is implemented. The physicist responsible for the system has to verify necessary system dosimetry for all beams used for patient treatment and imaging, in particular following a service intervention. Additionally, the necessary departmental QA procedures need to be followed. Siemens will also distribute information provided in the customer letter as an addendum to the user documentation.

Device

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • 모델명 / 제조번호(시리얼번호)
    MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd