Events

550 TxT Treatment Table used with 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-2014-RN-00157-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00157-1
  • 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 siemens attention that it is possible for patients or operators to have their fingers trapped and pinched between the table top and the bottom frame of the 550 txt treatment table.Secondly the manufacturer has received a report on an incident in which a cable inside the 550 txt treatment table has been damaged due to contacting a moving part. this resulted in a short circuit which overheated an electronic circuit board inside the table base.
  • 조치
    Siemens is advising users that the affected treatment tables will be modified to increase the gap between the table top and the base frame to more than 25mm to prevent fingers being trapped or pinched. Siemens will also be modifying the cable routing inside the patient table base in order to ensure the affected cable cannot contact moving parts.

Device

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • 모델명 / 제조번호(시리얼번호)
    550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear AcceleratorsCatalogue number: 7346534ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd