Events

ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Varian Medical Systems Australasia 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-2012-RN-01084-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-10-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01084-1
  • 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
    An anomaly has been identified with the aria oncology information system version 11 where monitor units of one fraction may be incorrect, when partial treatment is being continued. the issue happens when a treatment is interrupted mid-field (for example, by a power loss) and the delivered monitor units for the partially treated field are entered manually in the treatment record. when the partial treatment is resumed, the system will not use the full remaining planned monitor units for the affected field, thus leaving the fraction under dosed.
  • 조치
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.

Device

ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the ...
  • 모델명 / 제조번호(시리얼번호)
    ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)Product code: HITAffected serial numbers: HIT0339M and HIT0339R1ARTG Number: 132638
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd