Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option 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-2014-RN-00614-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-05
  • 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
    Siemens became aware of an incident where a patient was pinched between the moving gantry and the tabletop during an auto-sequenced treatment. in this case, an automatic gantry movement during an auto-sequenced treatment led to the collision because: - the auto-sequenced treatment has been created including beams with table angles. and - no dry run has been performed. and - the therapist did not monitor the patient during treatment delivery.
  • 조치
    Siemens is providing preventative work around instructions in its letter to customers, relating to beam placement, utilisation of dry runs after each change to the treatment plan, treatment interruption during patient repositioning, user care in field entries, patient monitoring and use of an optional inbuilt collision avoidance system such as ‘OPTIGARD’ if available. Additionally, therapist-identified potential collision between the gantry and the patient during use is preventable by the therapist by three separate button mechanisms. Siemens is also investigating a new method of determining whether there is a significant probability of collision between the LINAC gantry and the patient or the table.

Device

  • 모델명 / 제조번호(시리얼번호)
    Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option Catalogue/Lot number: LINAC Systems (Material Numbers 4505200, 5857912, 7360717, 8139789) with SIMTECARTG Number: 165502
  • Manufacturer

Manufacturer